ERAGON MODUBLADES 4393040Recalls & reported problems
Richard Wolf GmbH · METZENBAUM SCISSORS ATTACHMENT MONO PACK=10 PCS, for ERAGONmodublades insert and sheath, ERAGONmodular and ERAGONaxial handles, sterile, for single use · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207048658), received between May 22, 2025 and Jul 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT AFTER COMPLETION OF THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, PARTS OF THE PLASTIC INSULATION WERE DISCOVERED MISSING FROM THE DISPOSABLE SCISSORS. A NEW LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS PERFORMED AND THE MISSING PARTS WERE FOUND AND REMOVED.
Patient problems: Foreign Body In Patient
MAUDE report 22564380 ↗InjuryMay 22, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE INSULATION ON THE LAPAROSCOPIC SCISSORS BROKE AND A PIECE OF PLASTIC INSULATION CAME LOOSE IN THE PATIENT'S ABDOMEN. THE LOOSE PIECE WAS FOUND AND REMOVED.
Patient problems: Insufficient Information
MAUDE report 22070385 ↗
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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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