Surgical

Reports per year

Source: FDA adverse event reports by year received, 2025–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Modular Electromechanical Surgical SystemSCV1,200
• Staple, ImplantableGDW63
• Left Atrial Appendage Clip, ImplantablePZX3
• Pneumoperitoneum NeedleFHO2
• Clip, ImplantableFZP1
• Electrosurgical, Cutting & Coagulation & AccessoriesGEI1

Recent recalls

• 2026-07-10Open, ClassifiedProcess control

  da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

  Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.

• 2026-07-09Open, ClassifiedProcess control

  TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI code: M9461090040 TMINI Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components

  Due to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array.

• 2026-07-09Open, ClassifiedSoftware design (manufacturing process)

  Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

  Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

• 2026-07-02Open, ClassifiedUnder Investigation by firm

  Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

  Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

• 2026-07-02Open, ClassifiedUnder Investigation by firm

  Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

  Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

• 2026-06-22Open, ClassifiedProcess control

  Da Vinci ASSY, PSS, SP1098, Part Number: 380601

  Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

• 2026-06-18Open, ClassifiedSoftware design

  Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

  Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

• 2026-06-04Open, ClassifiedMixed-up of materials/components

  Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife

  3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

• 2026-06-04Open, ClassifiedDevice Design

  Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

  Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

• 2026-05-06Open, ClassifiedUnder Investigation by firm

  DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23

  Field Safety Corrective Action for IFU in DEX Forceps and Scissors.