Laparoscope, General & Plastic Surgery
FDA adverse event reports and recall history for laparoscope, general & plastic surgery (product code GCJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 82,825
- Deaths
- 261
- Injuries
- 6,899
- Malfunctions
- 74,527
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-02Open, ClassifiedNonconforming Material/Component
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
- 2025-10-24Open, ClassifiedUnder Investigation by firm
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- 2025-10-24Open, ClassifiedUnder Investigation by firm
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- 2025-10-24Open, ClassifiedUnder Investigation by firm
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- 2025-10-24Open, ClassifiedUnder Investigation by firm
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
- 2025-07-23Open, ClassifiedUnder Investigation by firm
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
- 2024-09-30Open, ClassifiedNonconforming Material/Component
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER MCKERNAN FUNDUS 5MM, 32CM, RATCHETED, REF SP90-7012; endoscopic surgical device
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- 2024-09-30Open, ClassifiedNonconforming Material/Component
Snowden-Pencer MIS DIAMOND-TOUCH GRASPER DIAMOND JAW BABCOCK 5MM, 32CM, RATCHETED, REF SP90-7018; endoscopic surgical device
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- 2024-09-30Open, ClassifiedNonconforming Material/Component
Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7020; endoscopic surgical device
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
- 2024-09-30Open, ClassifiedNonconforming Material/Component
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR FENESTRATED 16MM JAW 5MM, 32CM, NON RATCHETED, REF SP90-7036; endoscopic surgical device
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
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