Captura G56126Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002561267), received between Apr 21, 2017 and Dec 5, 2019 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 5, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE CLAW PART OF THE FORCEP WAS TWISTED AND WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER BIOPSY FORCEP. THIS EVENT WAS NOT REPORTABLE AT THE TIME. THE DEVICE WAS RECEIVED ON 12-NOV-2019 AND THE CUPS WERE 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 9419684 ↗
• MalfunctionAug 16, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE THE USER SELECTED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PACKAGING OF THE DEVICE WAS OPENED FOR COLORECTAL EXAMINATION. AFTER REMOVING THE CAP FROM THE FORCEPS, THE PHYSICIAN FOUND THAT THE TIP OF THE FORCEPS WAS "ALREADY SMASHED." THEREFORE, ANOTHER DEVICE WAS USED INSTEAD. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 23-JUL-2019 WITH THE CUPS MISALIGNED FROM SIDE TO SIDE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8903236 ↗
• MalfunctionMar 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY OF THE LARGE INTESTINE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE FORCEPS WERE TO BE USED FOR THE BIOPSY OF THE LARGE INTESTINE, HOWEVER THE CUPS WOULD NOT OPEN. ANOTHER DEVICE OF THE SAME LOT NUMBER WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 02/20/2018. THE FORCEPS CUPS WOULD OPEN, BUT NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7344820 ↗
• MalfunctionApr 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN UPPER GASTROINTESTINAL PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITHOUT SPIKE. DURING NORMAL SCOPING, THE FORCEPS WERE PLACED DOWN THE ENDOSCOPE TO TAKE A BIOPSY. THE FORCEPS EXITED ENDOSCOPE AND WERE OPENED, BUT COULD NOT CLOSE AFTER OPENING. THE CABLE BETWEEN HANDLE AND BIOPSY CUP [APPEARED TO BE] BROKEN. THEY WERE FINALLY ABLE TO GET THE FORCEPS CLOSED, AND REMOVED FROM THE ENDOSCOPE BUT COULD NOT REOPEN FORCEPS. TO FINISH THE PROCEDURE, AN NEW SET OF FORCEPS WERE OPENED AND USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6511359 ↗