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Captura G56073Recalls & reported problems

Cook Incorporated · Captura Serrated Large Forcep - Spike · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002560734), received between Jun 15, 2017 and Jul 27, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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

Device problems

  • Device Operates Differently Than Expected2

Patient problems

  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    IN PREPARATION FOR AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN CHOSE A CAPTURA SERRATED LARGE FORCEP- SPIKE. THE FORCEPS WERE OPENED, AND THEN THEY WOULD NOT CLOSE. ANOTHER OF THE SAME DEVICE WAS OPENED AND USED TO PROCEED WITH THE PROCEDURE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6746449 ↗
  • MalfunctionJun 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

    THE FOLLOWING WAS REPORTED ON (B)(6) 2017: DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. THE DEVICE WAS "BROKEN." THE DEVICE WAS RECEIVED FOR EVALUATION ON 05/24/2017. THE FORCEPS CUPS WOULD OPEN BUT WOULD NOT CLOSE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6643986 ↗

Other Endoscopic grasping/cutting instrument, non-powered, exempt devices

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