Captura G56131Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002561311), received between Sep 23, 2016 and Jul 13, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WENT DOWN THE ENDOSCOPE AND MADE CONTACT WITH THE POLYP. UPON CLOSURE OF THE FORCEPS, THE HAND PIECE SLIPPED AND THE FORCEPS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710468 ↗
• MalfunctionJul 10, 2017Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE USER TESTED THE FORCEPS BEFORE USE AND THEY OPENED. THE USER THEN PLACED THE FORCEPS DOWN THE ENDOSCOPE CHANNEL, AND WHILE THE FORCEPS WERE BEING PLACED DOWN THE CHANNEL, THE HANDLE "SLIPPED." THE FORCEPS NEVER TOUCHED THE MUCOSA. THE FORCEPS WERE TAKEN BACK OUT AND A NEW DEVICE (UNKNOWN MANUFACTURER AND MODEL) WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATION ON 06/22/2017. THE DEVICE WOULD OPEN BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697748 ↗
• MalfunctionJul 10, 2017Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WAS OPENED AND WHEN THE TECH TESTED IT, THE HAND PIECE SLIPPED. THIS DID NOT ALLOW THE FORCEPS TO OPEN AND CLOSE. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 6697747 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE BIOPSY FORCEPS WAS INTRODUCED VIA THE BIOPSY CHANNEL OF THE FLEXIBLE ENDOSCOPE AND THE JAWS OPENED. DURING THE PROCESS TO OBTAIN A BIOPSY, THE FORCEPS WOULD NOT CLOSE. THE TECHNICIAN OPERATING THE FORCEPS BELIEVES THEY HEARD A ¿POP¿. NO ATTEMPT MADE COULD CLOSE THE DEVICE. THE SURGEON HAD TO WITHDRAW THE ENDOSCOPE [FROM THE PATIENT'S MOUTH] AND MANUALLY CLOSE THE FORCEPS IN ORDER TO REMOVE THE DEVICE AND THE RE-INSERT THE ENDOSCOPE IN ORDER TO FINISH THE PROCEDURE. THEY USED ANOTHER DEVICE AND WERE SUCCESSFUL IN COMPLETING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680134 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE WOULD NOT OPEN OR CLOSE, BUT IT WAS NOTED PRIOR TO USE SO WAS NOT INTRODUCED DURING A PROCEDURE AND THROWN AWAY.

  Patient problems: No Patient Involvement

  MAUDE report 6680126 ↗
• MalfunctionSep 23, 2016Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEP WITH SPIKE. AS REPORTED TO CUSTOMER RELATIONS VIA ATTACHED COMPLAINT EMAIL, "THE SPECIMENS TAKEN WERE ALL ADEQUATE AND THE OPERATION OF THIS FORCEP WAS OTHERWISE SATISFACTORY EXCEPT THE DOCTOR AND ASSISTANT NOTICED NEAR THE END OF THE PROCEDURE THAT THE CUPS WHEN OPENED, WERE MOVING FROM SIDE TO SIDE, NOT STATIONARY. IT DID NOT AFFECT THE OUTCOME OR THE QUALITY OF THE SPECIMENS BUT THE OPEN CUPS DID MOVE FROM SIDE TO SIDE MAKING IT LOOK LIKE THEY WERE UNSTABLE OR WERE NOT ATTACHED PROPERLY. THE DOCTOR WONDERED IF THERE IS A DEFECT AND IF THIS IS SOMETHING SHE COULD EXPECT IF SHE SWITCHED TO THIS REFERENCE PART NUMBER (RPN). NONE OF THE OTHER FORCEPS IN THIS BOX BEHAVED LIKE THIS ONE SO WE ARE ALSO WONDERING IF IT HAS TO DO WITH THE MANUFACTURER'S PROCESS ON THIS ONE FORCEP. ON (B)(6) 2016, WE RECEIVED THE SUPPLIER EVALUATION OF THE DEVICE. THE CUPS WERE FOUND TO BE MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5973017 ↗