Electrocautery, Gynecologic (And Accessories)
FDA adverse event reports and recall history for electrocautery, gynecologic (and accessories) (product code HGI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 775
- Deaths
- 0
- Injuries
- 58
- Malfunctions
- 709
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2022-08-26Open, ClassifiedEnvironmental control
Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2014-12-02TerminatedPackaging process control
CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode
- 2012-10-03TerminatedNonconforming Material/Component
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
The wrong electrical connector pin was attached to the cord during assembly by the manufacturer. this electrical connector is too big to fit into the port on the foot activated generator. this makes the device unusable.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor - Small Model: 900-150
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor - Medium Model: 900-151
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor - Large Model: 900-152
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
- 2006-04-06TerminatedOther
Fischer Cone Biopsy Excisor Model: 900-157
Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.
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