Captura Pro G56999Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002569997), received between Apr 24, 2019 and Dec 2, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Difficult to Open or Close; Difficult to Open or Close

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT WHILE DOING A COLONOSCOPY, THE PHYSICIAN DID A SURVEILLANCE BIOPSY IN THE ASCENDING COLON. WHEN THE PHYSICIAN OPENED THE FORCEPS, THE FORCEPS OPENED BUT WOULD NOT CLOSE [SUBJECT OF THIS REPORT]. THE DEVICE WAS DOWN THE SCOPE BUT DIDN'T MAKE PATIENT [TISSUE] CONTACT. THE PHYSICIAN HAD TO PULL THE SCOPE OUT OF THE PATIENT AND HAD TO CUT THE BIOPSY FORCEPS OFF TO REMOVE IT FROM THE SCOPE CHANNEL. ANOTHER OF THE SAME PRODUCT NUMBER WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12917981 ↗
• MalfunctionJul 27, 2020Mechanical Problem; Dull, Blunt; Failure to Cut; Mechanical Problem; Dull, Blunt; Failure to Cut

  DURING MULTIPLE ENDOSCOPIC BIOPSIES, THE PHYSICIAN USED A TOTAL OF 22 COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE PHYSICIAN NOTICED THAT THE FORCEPS ARE NOT BITING THE TISSUE CLEANLY. THE TORN TISSUE LEFT BEHIND IS DESCRIBED AS "ZIPPER-LIKE". IT REQUIRED EXTRA FORCE TO BITE THE TISSUE. 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 10329862 ↗
• MalfunctionFeb 21, 2020Difficult to Open or Close; Difficult to Open or Close

  DURING A BIOPSY PROCEDURE, THE PHYSICIANS USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. AFTER TAKING A COUPLE OF BIOPSIES, THE PHYSICIAN NOTICED THAT THE DEVICE WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON (B)(6) 2020 INFORMATION WAS RECEIVED, NOTING THE FORCEPS WOULD OPEN, BUT WOULD NOT CLOSE. 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 9740680 ↗
• MalfunctionJan 14, 2020Difficult to Open or Close; Component Misassembled; Difficult to Open or Close; Component Misassembled

  PRIOR TO AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN OPENED THE PACKAGE OF A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE DEVICE WAS UNCOILED AND THE CUPS WERE IN THE OPEN POSITION. THE PHYSICIAN TRIED TO OPERATE THE DEVICE DURING TESTING AND THE CUPS WOULD NOT CLOSE. IT SEEMED AS IF THE DRIVE WIRE WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9587442 ↗
• MalfunctionApr 24, 2019Failure to Align; Failure to Align

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURE PRO¿ BIOPSY FORCEPS WITH SPIKE. THE USER FOUND A DEFECTIVE FORCEPS. A PIECE OF METAL WAS HANGING OFF THE SIDE OF THE FORCEPS JAW DURING A COLONOSCOPY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 26-MAR-2019. THE FORCEPS 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 8546805 ↗