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Captura G56060Recalls & reported problems

Cook Incorporated · Captura Serrated Max Forceps - Spike · Class 2

All models of Captura (37)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002560604), received between May 23, 2017 and Jun 2, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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 16, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected4

Patient problems

  • No Consequences Or Impact To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    DURING COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. THEY HEARD A SNAPPING SOUND IN THE HANDLE, AND THE FORCEPS WOULD NO LONGER OPEN NOR CLOSE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6608253 ↗
  • MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. DURING INITIAL BIOPSY, THERE WAS A SNAP HEARD IN THE HANDLE OF THE DEVICE AND THE DEVICE WOULD NEITHER OPEN NOR CLOSE AT THAT POINT. ANOTHER ONE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6591703 ↗
  • MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. ACCORDING TO THE USER, THERE WAS A "MALFUNCTION." THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2017. THE CUPS OF THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6585662 ↗
  • MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED MAX FORCEPS-SPIKE. ACCORDING TO THE USER, THERE WAS A "MALFUNCTION." THE DEVICE WAS RECEIVED FOR EVALUATION ON 04/28/2017. THE CUPS OF THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6585657 ↗

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Sources and updates

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