Captura G56135Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002561359), received between Jan 30, 2017 and Feb 26, 2020 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2020Failure to Align; Failure to Align

  DURING A COLONOSCOPY, THE PHYSICIAN USED COOK CAPTURA HOT SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN HAD TROUBLE GETTING THE DEVICE DOWN THE ENDOSCOPE. THE PHYSICIAN USED ADDITIONAL DEVICES FROM THE SAME GPN TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RECEIVED ON 04-FEB-2020 AND DETERMINED TO BE POTENTIALLY 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 9758281 ↗
• MalfunctionDec 2, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT SERRATED FORCEPS W/O SPIKE. UPON PASSING THE DEVICE DOWN THE COLONOSCOPE CHANNEL, THERE WAS DIFFICULTY PASSING IT ALL THE WAY THROUGH. AFTER THE SAMPLE WAS TAKEN, IT WAS EVEN MORE DIFFICULT TO REMOVE FROM THE COLONOSCOPE. [THIS EVENT WAS NOT REPORTABLE]. ON 05-NOV-2019 WHEN THE DEVICE WAS RETURNED, IT WAS NOTED THAT THE CUPS WERE MISALIGNED. ON 15-NOV-2019 THE SUPPLIER FOUND THE CUP ALIGNMENT WAS WITHIN SPECIFICATION, HOWEVER THERE WAS A GAP IN THE TEETH WHEN THE CUPS WERE CLOSED. 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 9398336 ↗
• MalfunctionOct 10, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, CAPATURA HOT SERRATED FORCEPS WITHOUT SPIKE. THE DEVICE WAS NOT WORKING PROPERLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON (B)(6) 2019 AND FOUND TO BE POTENTIALLY MISALIGNED AND HAD A GAP IN THE TEETH. THE SUPPLIER EVALUATION DETERMINED THE FORCEPS CUPS ARE WITHIN SPECIFICATION OF CUP ALIGNMENT. HOWEVER, OUR INITAL INVESTIGATION FINDINGS INDICATE THE FORCEPS HAD GAPS IN THE TEETH (SUBJECT OF REPORT). OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176759 ↗
• MalfunctionSep 6, 2019Failure to Align; Failure to Align

  THE FOLLOWING WAS INITIALLY REPORTED "DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) COOK CAPTURE HOT SERRATED FORCEPS W/O SPIKE. THE HOT FORCEPS BROKE DURING CASE. THE FORCEPS WERE REMOVED FROM THE ENDOSCOPE WITH NO INJURY TO THE PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICES WERE EVALUATED ON (B)(6) 2019 AND IT WAS DETERMINED THAT THE FORCEP CUPS WERE POTENTIALLY MISALIGNED AND HAD GAPS IN THE TEETH." THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE APPROVED SUPPLIER. THE FORCEPS CUPS ARE WITHIN SPECIFICATION OF CUP ALIGNMENT FOR BOTH DEVICES. HOWEVER, OUR INITIAL INVESTIGATION FINDINGS INDICATE BOTH FORCEPS HAD GAPS IN THE TEETH (SUBJECT OF REPORT). 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 8971844 ↗
• MalfunctionMay 24, 2019Failure to Align; Difficult to Open or Close; Failure to Align; Difficult to Open or Close

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT SERRATED FORCEPS WITHOUT SPIKE. THE DEVICE WAS USED TO TAKE A BIOPSY. THEN, THE PHYSICIAN SNARED A POLYP AND TRIED TO USE THE BIOPSY FORCEP TO CAUTERIZE THE BLEEDING AND WHEN THE PHYSICIAN PUT THE BIOPSY FORCEP BACK IN, THE JAWS WERE "JUST FLOPPING AROUND". THE HANDLE WAS NOT WORKING. IT SEEMS AS THOUGH THE WIRE WAS BROKEN ON THE DEVICE. A NEW [DEVICE OF THE SAME TYPE] WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATED AND ALSO FOUND TO BE POTENTIALLY 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 8640969 ↗
• MalfunctionJul 7, 2017Failure to Align; Failure to Align

  DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) COOK CAPTURA HOT SERRATED FORCEPS W/O SPIKE. FOR THE FIRST DEVICE, THEY CLOSED THE CUPS TO TAKE A BITE OF TISSUE AND SOMETHING SNAPPED AT THE HANDLE (SEE RELATED MDR 1037905-2017-00454). THE SECOND DEVICE WAS BEING PLACED DOWN THE SCOPE AND "SOMETHING DID NOT FEEL RIGHT", SO THE FORCEPS WERE REMOVED AND IT WAS NOTICED THAT THE CUPS WERE BENT (SUBJECT OF THIS REPORT). THE DEVICES WERE EVALUATED ON 06/15/2017. ONE DEVICE WOULD OPEN BUT WOULD NOT CLOSE (SEE RELATED MDR 1037905-2017-00454) AND THE SECOND DEVICE WAS FOUND TO BE POTENTIALLY MISALIGNED (SUBJECT OF THIS REPORT).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693006 ↗
• MalfunctionJul 7, 2017Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) COOK CAPTURA HOT SERRATED FORCEPS W/O SPIKE. FOR THE FIRST DEVICE, THEY CLOSED THE CUPS TO TAKE A BITE OF TISSUE AND SOMETHING SNAPPED AT THE HANDLE (SUBJECT OF THIS REPORT). THE SECOND DEVICE WAS BEING PLACED DOWN THE SCOPE AND "SOMETHING DID NOT FEEL RIGHT", SO THE FORCEPS WERE REMOVED AND IT WAS NOTICED THAT THE CUPS WERE BENT (SEE RELATED MDR 1037905-2017-00455). THE DEVICES WERE EVALUATED ON 06/15/2017. ONE DEVICE WOULD OPEN BUT WOULD NOT CLOSE (SUBJECT OF THIS REPORT) AND THE SECOND DEVICE WAS FOUND TO BE POTENTIALLY MISALIGNED (SEE RELATED MDR 1037905-2017-00455).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693005 ↗
• MalfunctionJan 30, 2017Break; Break

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA HOT SERRATED FORCEPS W/O SPIKE. AS REPORTED TO CUSTOMER RELATIONS: "DURING A COLONOSCOPY PROCEDURE THE DEVICE WAS PLACED DOWN THE ENDOSCOPE AND WHILE UNDER MAGNIFICATION THE PHYSICIAN NOTED FRAYED SHEATHING AND METAL. [FORCEPS OUTER SHEATH IS DAMAGED]. REMOVED THE DEVICE AND USED ANOTHER OF THE SAME PRODUCT TO COMPLETE THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6285715 ↗