Captura G56059Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00827002560598), received between Oct 17, 2016 and May 29, 2018 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE FORCEPS WOULD NOT OPEN AND CLOSE CORRECTLY. THE DEVICE IS BROKEN WHERE THE DRIVE WIRE CONNECTS TO THE HANDLE. THEY PUT IT DOWN THE ENDOSCOPE AND IT WOULD NOT OPEN OR CLOSE. THEY OPENED A NEW DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7549325 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE FORCEPS WERE BROKEN AT THE HANDLE. THE FOLLOWING WAS RECEIVED ON 10/09/2017 PER THE SALES REPRESENTATIVE: "EACH OF THE FORCEPS THAT THE CUSTOMER REPORTED HAD BROKEN AT THE HANDLE WERE TESTED (OUTSIDE THE ENDOSCOPE) ONCE GIVEN TO ME. THEY DID NOT FEEL AS IF THEY WERE FUNCTIONING CORRECTLY, MEANING THAT THEY FELT AS IF THE DRIVE WIRE OR A SET SCREW WAS LOOSE OR BROKEN. THIS AFFECTED THE OPENING AND CLOSING OF THE CUPS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6931194 ↗
• MalfunctionOct 9, 2017Failure to Align; Device Operates Differently Than Expected; Failure to Align; Device Operates Differently Than Expected

  IN PREPARATION FOR A COLONOSCOPY PROCEDURE, THE USER SELECTED THREE (3) COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE FORCEPS WERE BROKEN AT THE HANDLE PRIOR TO USE. THE DEVICE WAS RECEIVED FOR EVALUATION ON 09/28/2017.THE CUPS WERE FOUND TO BE POTENTIALLY MISALIGNED. THE FOLLOWING WAS RECEIVED ON 10/09/2017 PER THE SALES REPRESENTATIVE: "EACH OF THE FORCEPS THAT THE CUSTOMER REPORTED HAD BROKEN AT THE HANDLE WERE TESTED (OUTSIDE THE ENDOSCOPE) ONCE GIVEN TO ME. THEY DID NOT FEEL AS IF THEY WERE FUNCTIONING CORRECTLY, MEANING THAT THEY FELT AS IF THE DRIVE WIRE OR A SET SCREW WAS LOOSE OR BROKEN. THIS AFFECTED THE OPENING AND CLOSING OF THE CUPS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6931110 ↗
• MalfunctionOct 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE FORCEPS BROKE AT THE HANDLE. THE FOLLOWING WAS RECEIVED ON 10/09/2017 PER THE SALES REPRESENTATIVE: "EACH OF THE FORCEPS THAT THE CUSTOMER REPORTED HAD BROKEN AT THE HANDLE WERE TESTED (OUTSIDE THE ENDOSCOPE) ONCE GIVEN TO ME. THEY DID NOT FEEL AS IF THEY WERE FUNCTIONING CORRECTLY, MEANING THAT THEY FELT AS IF THE DRIVE WIRE OR A SET SCREW WAS LOOSE OR BROKEN. THIS AFFECTED THE OPENING AND CLOSING OF THE CUPS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6931105 ↗
• MalfunctionOct 6, 2017Dull, Blunt; Dull, Blunt

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE FORCEPS WOULD NOT TAKE A CLEAN BITE OF TISSUE. THE DEVICE WAS TEARING THE TISSUE.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 6921770 ↗
• MalfunctionOct 6, 2017Failure to Align; Failure to Align

  DURING A COLONOSCOPY, THE PHYSICIAN USED FIVE (5) CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE FORCEPS ARE TEARING THE TISSUE.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 6921727 ↗
• MalfunctionSep 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE HANDLE BROKE WHEN THE USER OPENED DURING THE FIRST PASS. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 9/11/2017 FROM A COOK CLINICAL SPECIALIST: "I WAS TOLD THE CUPS OPENED BUT THEN WOULD NOT CLOSE BY THE HANDLE. THEY CLOSED AS THE PHYSICIAN PULLED THE FORCEPS INTO THE SCOPE." THE DEVICE WAS EVALUATED ON 9/11/2017. IT WAS CONFIRMED THAT THE FORCEPS CUPS WOULD OPEN BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6893161 ↗
• InjuryAug 3, 2017Material Separation; Device Operates Differently Than Expected; Material Separation; Device Operates Differently Than Expected

  DURING A UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - NO SPIKE. THE FORCEPS WERE INTRODUCED DOWN THROUGH THE CHANNEL OF THE OLYMPUS 180 ENDOSCOPE. ONE BIOPSY WAS OBTAINED. THE USER OPENED THE FORCEPS AGAIN AND THE DEVICE COLLAPSED. THE PIECE OF FORCEPS THAT CAME OFF IN THE PATIENT WHEN IT COLLAPSED WAS RETRIEVED WITH NO HARM TO THE PATIENT. ANOTHER FORCEPS WAS USED FROM A DIFFERENT BOX AND PROCEDURE COMPLETED WITH NO FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6764886 ↗
• MalfunctionAug 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING FOUR (4) SEPARATE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED A CAPTURA SERRATED LARGE FORCEP-NO SPIKE IN EACH PROCEDURE [TOTAL OF FOUR (4) REPORTED DEVICES]. THE CABLES BROKE DURING THE FIRST BITE. THE DEVICES WOULD THEN NO LONGER OPEN OR CLOSE. THIS OCCURRED ONE TIME EACH IN FOUR (4) DIFFERENT CASES WITH THIS LOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6763022 ↗
• MalfunctionAug 3, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE CABLE BROKE DURING THE FIRST BITE. THE DEVICE WOULD THEN NO LONGER OPEN OR CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6763020 ↗
• MalfunctionAug 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR AN UPPER ENDOSCOPY, THE PHYSICIAN SELECTED A CAPTURA SERRATED LARGE FORCEP- NO SPIKE. DURING PRETESTING, THE PHYSICIAN OPENED AND CLOSED THE FORCEPS AND THEY "COLLAPSED". THEY WERE PUT ASIDE AND ANOTHER PAIR OF FORCEPS WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760350 ↗
• MalfunctionAug 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - NO SPIKE. THE CABLE BROKE AND THE FORCEPS CANNOT BE CONTROLLED BY THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760348 ↗
• MalfunctionJun 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED TWO (2) COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. "THE DRIVE CABLE BROKE ON A COUPLE [OF FORCEPS]. NO ONE HURT, NOTHING LEFT IN THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6668527 ↗
• MalfunctionJun 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS-NO SPIKE. THE FORCEPS WERE PRE-TESTED AND WHEN THEY GOT TO THE TARGETED SITE THEY WERE UNABLE TO CLOSE THE FORCEPS ONCE IT WAS OPENED. THEY HAD TO CUT THE FORCEPS, DISTAL OF THE FORCEPS HANDLE, TO REMOVE THE DEVICE FROM THE ENDOSCOPE. THEY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664022 ↗
• MalfunctionJun 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS -NO SPIKE. THE FORCEPS WORKED FOR 2-3 BITES, THEN AFTER THAT, WHILE TAKING A BIOPSY IN THE STOMACH ANTRUM, THE FORCEPS GOT STUCK OPEN/HANDLE SNAPPED. THE ENDOSCOPE AND DEVICE WERE REMOVED TOGETHER AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644801 ↗
• MalfunctionApr 18, 2017Dull, Blunt; Dull, Blunt

  DURING SEPARATE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED THIRTEEN (13) COOK CAPTURA SERRATED LARGE FORCEPS WITHOUT SPIKE. THE FORCEPS ARE CAUSING THE TISSUE TO "TENT UP" AND IS TEARING MUCOSA.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 6501416 ↗
• MalfunctionApr 18, 2017Dull, Blunt; Dull, Blunt

  DURING SEPARATE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED ELEVEN (11) COOK CAPTURA SERRATED LARGE FORCEP WITHOUT SPIKE. THE FORCEPS ARE CAUSING THE TISSUE TO "TENT UP" AND IS TEARING MUCOSA.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 6501415 ↗
• MalfunctionOct 17, 2016Detachment Of Device Component; Detachment Of Device Component

  DURING AN COLONOSCOPY, THE PHYSICAN USED A COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. UPON PUTTING THE FORCEP DOWN THE ENDOSCOPE, THE FORCEP GOT STUCK HALFWAY DOWN. UPON REMOVING THE FORCEP FROM THE ENDOSCOPE, THERE WAS DIFFICULTY REMOVING THE FORCEP AND THE FORCEP BROKE. THE TIP OF THE FORCEP DETACHED AND WAS ABLE TO BE REMOVED FROM THE ENDOSCOPE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6034488 ↗