ERAGON MODULAR 8393184Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207015810), received between Sep 20, 2022 and Jun 24, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Insufficient Device Problem Information

  ACCORDING TO THE REPORT, THE FORCEPS HAVE CAUSED TRAUMATIC LESIONS, SOME OF WHICH WITH TRANSMURAL PERFORATION. PATIENT REQUIRING SURGICAL RE-INTERVENTION DUE TO SMALL BOWEL PERFORATIONS. THE USER DID NOT SPECIFY WHETHER A MALFUNCTION OCCURRED WHILE THE FORCEPS WERE BEING USED OR EXACTLY WHAT CIRCUMSTANCES LED TO THE PATIENT'S INJURY.

  Patient problems: Bowel Perforation

  MAUDE report 25607356 ↗
• MalfunctionSep 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  RICHARD WOLF GMBH COMPLAINT REFERENCE (B)(4). USER REPORT MV-2002-00463 IN FRANCE. THE USER HAS REPORTED THE FOLLOWING: GRIPPING FORCEPS TOO TRAUMATIC FOR THE SMALL INTESTINE AND DIGESTIVE TRACT REPEATED WOUNDS, REQUIRING MODIFICATION OF THE PROCEDURE, SUTURES ETC... CLINICAL CONSEQUENCE: PERITONITIS, RECOVERY, MAJOR RISK. RWGMBH AWARENESS DATE, 22-AUG-2022.

  Patient problems: Peritonitis; Wound Dehiscence

  MAUDE report 15455463 ↗