Captura G56061Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002560611), received between Oct 17, 2017 and Apr 16, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN CHOSE A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE VALVE [HANDLE] THAT OPENS AND CLOSES [THE CUPS] HAS BROKEN OFF, SO IT WILL NOT WORK PROPERLY ANYMORE. WHEN USING IT, THE CUP SNAPS. THE MECHANISM OF OPEN AND CLOSE FAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7433239 ↗
• MalfunctionApr 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN CHOSE A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE VALVE (HANDLE) THAT OPENS AND CLOSES (THE CUPS) HAS BROKEN OFF, SO IT WILL NOT WORK PROPERLY ANYMORE. WHEN USING IT, THE CUP SNAPS. THE MECHANISM OF OPEN AND CLOSE FAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7433238 ↗
• MalfunctionOct 17, 2017Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE DEVICE WAS TO BE USED FOR UPPER GASTROINTESTINAL ENDOSCOPY. THE CUPS DID NOT OPEN OR CLOSE SMOOTHLY WHEN THE PHYSICIAN CHECKED THE DEVICE FUNCTION PRIOR TO PATIENT CONTACT. ANOTHER CAPTURA BIOPSY FORCEPS WITHOUT SPIKE WAS USED INSTEAD FOR THE PROCEDURE. THIS DEVICE EVALUATED ON (B)(6) 2017. DURING OUR EVALUATION, THE CUPS WOULD OPEN BUT COULD NOT CLOSE WHEN HANDLE WAS BEING ACTUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6954182 ↗