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Cook G35215Recalls & reported problems

Cook Incorporated · Transluminal Biliary Biopsy Forceps Set · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002352155), received between Nov 9, 2017 and Nov 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionNov 9, 2017Detachment Of Device Component; Detachment Of Device Component

    THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A LIVER BIOPSY, THE FORCEPS IN THE TRANSLUMINAL BILIARY BIOPSY FORCEPS MINIMAL SET PARTIALLY DETACHED FROM THE INTRODUCER. HOWEVER, THEY WERE STILL ATTACHED BY A SMALL THREAD. THE OPERATOR OF THE DEVICE CHANGED THE FORCEPS SET. NO PATIENT ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE REPORTED PRODUCT ISSUE. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7013527 ↗

Other FORCEPS, BIOPSY, NON-ELECTRIC devices

All FORCEPS, BIOPSY, NON-ELECTRIC devices →

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