Irrigating Disposable Bipolar Forceps 8" X 0.5mm 9008050IRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10817489027209), received between Mar 23, 2021 and Mar 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2021Inaccurate Information

  CODMAN IRRIGATING DISPOSABLE BIPOLAR FORCEPS WERE FOUND TO HAVE A 3M INDICATOR/ INSTRUMENT PROTECTOR IN THEM WHERE THE ETHYLENE OXIDE INDICATOR DID NOT CHANGE ON SOME OF THE FORCEPS PACKAGING. CONTACTED CODMAN REP ABOUT THIS ISSUE. THEIR SUPERIOR AND QUALITY DEPARTMENT STATED THE 3M INDICATOR/INSTRUMENT PROTECTOR WERE ONLY PLACE HOLDERS. THE INDICATOR THAT IS USED TO DETERMINE STERILITY IS PLACED ON THE EXTERIOR OF THE CORRUGATED SHIPPING BOX. THE STICKER ON THE OUTSIDE IS PURPLE AND WILL TURN GREEN WHEN IN CONTACT WITH THE ETHYLENE OXIDE (EO). THIS DOT INDICATOR IS USED TO INDICATE STERILIZATION BY EO FOR THESE DISPOSABLES. THERE ARE 5 BIPOLAR FORCEPS (DOUBLE PEEL PACKAGES FOR EACH DISPOSABLE FORCEP) IN A WHITE CARDBOARD BOX AND SEVERAL WHITE CARDBOARD BOXES ARE PACKAGED WITHIN THE CORRUGATED SHIPPING BOX. MULTIPLE REF#S AND LOT#S INVOLVED - 3 EXAMPLES ADDED TO THIS EVENT. THE 3M INDICATOR/INSTRUMENT PROTECTOR HAS 2 YELLOW DIAMONDS FOR EO THAT WILL CHANGE TO RUST/RED IF EXPOSED TO EO APPROPRIATELY. SOME OF THE 3M INDICATORS CHANGED APPROPRIATELY AND SOME REMAINED YELLOW. WE QUESTION IF THE EO GAS EFFECTIVELY PENETRATED THROUGH ALL PACKAGING TO 3M INDICATOR AND IF CONTENTS ARE STER

  Patient problems: Insufficient Information

  MAUDE report 11553289 ↗