Captura G53633Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002536333), received between Oct 17, 2017 and Dec 6, 2018 — classified as 3 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. 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.

• MalfunctionDec 6, 2018Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - NO SPIKE. THE TIP HAD FOLDED AT THE END OF THE PROCEDURE. THE BRANCHES [CUPS] OF THE FORCEPS ARE SLIGHTLY BENT AT THE DISTAL END AND NOT SYMMETRICALLY STRAIGHT [CUPS BENT OVER AT CUP FLANGE]. THE CUPS CAN BE OPENED AND CLOSED. THE HANDLING WAS THEREFORE DIFFICULT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 11/13/2018 AND FOUND TO BE MISALIGNED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8139556 ↗
• MalfunctionJan 8, 2018Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - NO SPIKE. THEY WANTED TO TAKE BIOPSIES. AFTER ADVANCING THE FORCEPS OUT OF THE WORKING CHANNEL, IT WAS NOT POSSIBLE TO OPEN THE CUPS. THE DEVICE WAS EVALUATED ON 12/14/2017 AND THE CUPS WERE FOUND TO OPEN, BUT NOT CLOSE UPON HANDLE MANIPULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7171605 ↗
• MalfunctionOct 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A GASTROSCOPY PROCEDURE THE PHYSICIAN USED THREE (3) COOK CAPTURA SERRATED LARGE FORCEP - NO SPIKE. THE DRIVE WIRE BROKE WHEN USING THE FORCEPS. THE NURSE WANTED TO CLOSE FORCEPS TO TAKE SAMPLES IN STOMACH, THEN SHE REALIZED THAT THERE WAS RESISTANCE TO CLOSE THE CUPS AND THAT THEY WERE NOT REACTING ANYMORE. THE FORCEPS WERE TAKEN OUT AND A NEW ONE WAS USED. THEY EXPERIENCED THIS WITH THREE (3) FORCEPS BUT HAVE ONLY ONE (1) TO BE SENT IN [FOR EVALUATION].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6955666 ↗