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ERAGON MODULAR 8393041Recalls & reported problems

Richard Wolf GmbH · METZENBAUM SCISSORS INSERT Ø 5MM jaw length 23mm, for SL 330mm, double action, reusable · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207015711), received between Oct 18, 2018 and Feb 15, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Material Twisted/Bent1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Burn(s)1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 15, 2023Material Twisted/Bent; Material Twisted/Bent

    THE USER FACILITY CLAIMED THAT "WE WERE FACED WITH THE SAME PROBLEM WITH 2 METZENBAUM SCISSOR INSERTS (REF: 8393.041) DELIVERED ON (B)(6). DURING OPERATIONS, THE JAWS OF THE SCISSORS BECAME UNSUITABLE. ONE OF THEM WAS USED ONCE, THE OTHER WAS USED THREE TIMES. THEY ARE PART OF THE SAME BATCH (1516371)." THERE WAS NO HARM TO THE PATIENT AND NO COMPONENT OF THE SCISSORS WAS LOST. THE TREATMENT WAS COMPLETED WITH ANOTHER PAIR OF SCISSORS, BUT THERE WAS A SURGERY DELAY OF 1 HOUR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16380840 ↗
  • MalfunctionSep 23, 2022Mechanical Problem; Mechanical Problem

    RICHARD WOLF GMBH REFERENCE COMPLAINT (B)(4) (FU1 MDR / ADDITIONAL INFORMATION - DEVICE NOT RETURNED) THE PURPOSE OF THIS SUBMISSION IS TO REPORT THAT DEVICE EVALUATION IS NOT AVAILABLE DUE TO DEVICE NOT RETURNED TO MANUFACTURER FOR INVESTIGATION. (SEE H10) DEVICE NOT RETURNED: RWGMBH AWARENESS DATE, 18-JAN-2023.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15473878 ↗
  • MalfunctionOct 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH NEW AND CHANGED INFORMATION.

    Patient problems: Burn(s)

    MAUDE report 7981728 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.