ERAGON BIPOLAR 83930041Recalls & reported problems
Richard Wolf GmbH · METZENBAUM SCISSORS INSERT Ø 5.5MM jaw length 22mm, for SL 320mm, double action, reusable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207026588), received between Feb 27, 2020 and Apr 3, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2020Break; Break
ON SEPTEMBER 24, 2019, RICHARD WOLF (B)(4) RECEIVED THE FOLLOWING INFORMATION: DURING INTRAOPERATIVE USE OF THE BIPOLAR SCISSORS, THE CERAMIC BLADE AT THE DISTAL END OF THE INSTRUMENT FELL OFF DURING APPLICATION UNDER HF. THE CERAMIC BLADE WAS COMPLETELY RECOVERED. NO SIGNIFICANT SURGERY TIME EXTENSION IS REPORTED. THE CERAMIC WAS FULLY RECOVERED FROM THE PATIENT DURING THE SURGERY. THE APPLICATION WAS COMPLETED. NO DETERIORATION OF THE PATIENT'S CONDITION AFTER APPLICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9924028 ↗MalfunctionFeb 27, 2020Break; Break
ON AUGUST 20, 2019, RICHARD WOLF GMBH (RW GMBH) RECEIVED THE FOLLOWING INFORMATION: DURING INTRAOPERATIVE USE OF THE BIPOLAR SCISSORS, THE CERAMIC BLADE AT THE DISTAL END OF THE INSTRUMENT FELL OFF DURING APPLICATION UNDER HF (HF GENERATOR: MARTIN MAXIMUM ME402). THE CERAMIC BLADE WAS COMPLETELY RECOVERED. NO SIGNIFICANT SURGERY TIME EXTENSION IS REPORTED. THE CERAMIC WAS FULLY RECOVERED FROM THE PATIENT DURING THE SURGERY. THE APPLICATION WAS COMPLETED. NO DETERIORATION OF THE PATIENT'S CONDITION AFTER APPLICATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9764256 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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