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Cook G05533Recalls & reported problems

Cook Incorporated · Cook Flexible Biopsy Forceps Elongated Cup · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002055339), received between Jan 16, 2018 and Jan 16, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Open or Close” (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

  • Difficult to Open or Close1

Patient problems

  • No Code Available1

Recent adverse event reports

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

  • InjuryJan 16, 2018Difficult to Open or Close; Difficult to Open or Close

    IT WAS REPORTED THAT DURING A BIOPSY, THE COOK FLEXIBLE MYOCARDIAL BIOPSY FORCEPS DID NOT CLOSE PROPERLY. MYOCARDIAL TISSUE WAS UNABLE TO BE CAPTURED AS A RESULT. AS NO OTHER FORCEPS WERE AVAILABLE, THE PROCEDURE WAS UNABLE TO BE COMPLETED AND WAS CANCELLED. ADDITIONAL INFORMATION REGARDING HOW THE PROCEDURE WAS COMPLETED, EVENT DETAILS, AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Patient problems: No Code Available

    MAUDE report 7194416 ↗

Other DEVICE, BIOPSY, ENDOMYOCARDIAL devices

All DEVICE, BIOPSY, ENDOMYOCARDIAL devices →

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