Captura G31576Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00827002315761), received between Apr 21, 2017 and Nov 3, 2025 — classified as 2 injuries, 17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Failure to Cut; Failure to Cut

  DURING AN ENDOSCOPIC BIOPSY SAMPLING IN THE ESOPHAGUS, THE PHYSICIAN CHOSE A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND ADVANCED THE DEVICE THROUGH ENDOSCOPE WORKING CHANNEL TO OPERATE WHILE FOUND OUT THE CUP TIP IS TOO BLUNT TO CAPTURE THE TISSUE AND CAUSE LARGE WOUND [AND] CAUSED SIGNIFICANT BLOOD LOSS. THE USER CHANGED TO ANOTHER BIOPSY FORCEPS TO OBTAIN THE SAMPLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. REQUESTS HAVE BEEN MADE BUT IT IS UNKNOWN HOW THE BLEEDING WAS STOPPED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 23458029 ↗
• InjuryMar 28, 2025Failure to Cut; Failure to Cut

  DURING AN ESOPHAGEAL BIOPSY PROCEDURE, THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT USER DETECTED THE CUP STICK, AND CANNOT CUT THE TARGET TISSUE, CAUSE LARGE TRAUMA AND SERIOUS BLEEDING. AT THE TIME OF THIS REPORT, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAVE BEEN UNSUCCESSFUL. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 21717755 ↗
• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  THIS SUPPLEMENTAL EMDR IS BEING SENT TO CANCEL THE INITIAL EMDR. SEE H11 FOR FURTHER JUSTIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717696 ↗
• MalfunctionMar 29, 2024Difficult to Open or Close; Difficult to Open or Close

  IN PREPARATION FOR A COLONOSCOPY EXAMINATION, THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE NURSE OPENED THE OUTER PACKAGING OF THE DISPOSABLE BIOPSY FORCEPS AND INSPECTED THE BIOPSY FORCEPS HEAD. WHEN THE COLONOSCOPE WAS USED, IT WAS DISCOVERED THE FORCEPS HEAD WAS BENT AND THE FORCEPS FLAP WAS STUCK IN OPEN POSITION. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19002687 ↗
• MalfunctionMar 25, 2024Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  DURING A COLONOSCOPY ON A 72 YEAR OLD MALE PATIENT, THE PHYSICIAN USED A CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED BY THE PHYSICIAN THAT DURING THE PROCEDURE, WHEN THE CLAMP IS OPENED, THE BOWLS [JAWS] ARE BENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON (B)(6) 2024, WE RECEIVED THE DEVICE FOR EVALUATION. QE INITIAL EVALUATION WAS THAT THE BOWLS WERE BENT TO ONE SIDE. THE CUPS WOULD OPEN AND CLOSE, HOWEVER, THE BOWLS WOULD NOT FULLY STRAIGHTEN WHEN CLOSED AND WERE ALMOST AT A 90 DEGREE ANGLE WHEN OPENED. ONE SIDE OF THE LINK WIRES IS COMPLETELY BROKEN. THE CUPS WERE NOT MISALIGNED, THEY MESHED TOGETHER AS EXPECTED. THIS CHANGES THE INITIAL REPORTING DECISION FROM NOT REPORTABLE TO REPORTABLE. 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 18968088 ↗
• MalfunctionMay 11, 2023Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  IN PREPARATION FOR AN UNKNOWN ENDOSCOPIC PROCEDURE. THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED, THAT THE USER OPENED THE PACKAGE AND FOUND OUT THE CUP DEVIATED, THE BIOPSY HEAD WAS CROOKED. THE DEVICE WAS NOT USED ON PATIENT. AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THE TIME. THE DEVICE WAS RECEIVED FOR EVALUATION. AND PER THE INITIAL ASSESSMENT FROM QE, THE FORCEPS ARE UNABLE TO CLOSE [SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT. THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE. AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16914747 ↗
• MalfunctionJul 18, 2022Fracture; Difficult to Open or Close; Material Twisted/Bent; Fracture; Difficult to Open or Close; Material Twisted/Bent

  DURING AN ENDOSCOPIC PROCEDURE FOR BIOPSY SAMPLING, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT DURING THE BIOPSY SAMPLING, THE FORCEPS DID NOT OPEN CORRECTLY AND BROKE AT THE BASE OF THE BIT [JAWS]. IT WAS ALSO REPORTED THAT IT WAS IMPOSSIBLE TO REMOVE THE BIOPSY FORCEPS FROM INSIDE THE PATIENT. THE PHYSICIAN HAD TO STOP THE EXAMINATION TO BE ABLE TO REMOVE THE BIOPSY FORCEPS FROM GASTROSCOPE. 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 15042940 ↗
• MalfunctionDec 17, 2020Difficult to Open or Close; Difficult to Open or Close

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS STOPPED WORKING DURING THE PROCEDURE, AFTER THE FIRST BIOPSY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 24-NOV-2020 INDICATED THAT THE FORCEPS WOULD NOT CLOSE [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 11030307 ↗
• MalfunctionSep 28, 2020Failure to Align; Failure to Align

  DURING A SEVERAL BIOPSY PROCEDURES, THE PHYSICIAN SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS CUPS WERE OUT OF ALIGNMENT WHEN THE PHYSICIAN TRIED TO TAKE THE SPECIMEN .THE EDGES DID NOT MEET. ADDITIONAL INFORMATION STATED THAT THIS HAS OCCURRED SEVERAL TIMES. THE PHYSICIAN HAD TO OPEN ANOTHER PAIR OF FORCEPS WHEN THIS OCCURRED. 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 Known Impact Or Consequence To Patient

  MAUDE report 10597385 ↗
• MalfunctionJul 5, 2018Peeled/Delaminated; Peeled/Delaminated

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS FELL APART INSIDE THE PATIENT. THE BLACK COVERING ON THE END OF THE FORCEPS CAME OFF INSIDE THE PATIENT, AND THE FORCEPS FAILED TO FUNCTION [DIFFICULT TO OPEN]. THE PHYSICIAN HAD TO WITHDRAW THE ENDOSCOPE TO REMOVE THE FORCEPS. THEY WERE ALSO ABLE TO RETRIEVE THE BLACK COVERING BY USING ANOTHER FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE COVERING WAS RETRIEVED BY FORCEPS. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 7664490 ↗
• MalfunctionJul 2, 2018Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE DEVICE WAS ADVANCED TO DESIRED POSITION, AND THE USER FELT IT WAS MUCH HARDER USING FORCEPS THAN USUAL. THE PROCEDURE WAS PROLONGED DUE TO ABOVE ISSUE, AND USER PUT MORE EFFORT TO COMPLETE THE FIRST BIOPSY SAMPLING. THERE WAS OBVIOUS RESISTANCE MET WHILE RETRACTING THE DEVICE FROM ENDOSCOPE BIOPSY CHANNEL. THE DEVICE WAS EVALUATED ON 07-JUNE-2018 AND FOUND TO HAVE MISALIGNED CUPS. 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 7656567 ↗
• MalfunctionJun 15, 2018Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. PER THE USER, IT WAS IMPOSSIBLE TO TAKE A SAMPLE FOR BIOPSY. THE FORCEPS DID NOT CUT THE MUCOSA WHEN THE SPOON [CUPS] CLOSED. THERE WAS NO SHARP EDGE ON THE SPOON CUT [FORCEPS CUPS]. THEY CHANGED THE FORCEPS [TO COMPLETE THE BIOPSY]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 05/22/2018 AND THE FORCEPS CUPS WERE FOUND TO BE POTENTIALLY MISALIGNED. THE SUPPLIER EVALUATION WAS RECEIVED ON 06/13/2018. THE FORCEPS CUPS WERE FOUND TO BE ALIGNED. HOWEVER, THERE WAS A GAP BETWEEN THE EDGES OF THE CUPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7607546 ↗
• MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED TWO (2) COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS JAWS ARE NOT FUNCTIONING (OPENING OR CLOSING).

  Patient problems: No Patient Involvement

  MAUDE report 7303143 ↗
• MalfunctionDec 11, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY SCREENING, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FOLLOWING WAS PROVIDED TO A COOK DIRECTOR [NON-(B)(6) SPEAKING] IN AN EMAIL IN (B)(6) ON 05/22/2017: "PLEASE FIND ATTACHED AN ADVERSE EVENT STATEMENT WITH A BIOPSY FORCEPS. THE OFFENDING DM [MEDICAL DEVICE] IS AVAILABLE AT THE PUI [FACILITY] IF YOU WISH. THANK YOU FOR LETTING US KNOW WHAT YOU WILL DO WITH THIS STATEMENT." THE DOCUMENT ATTACHED TO THE EMAIL WAS ALSO IN (B)(6). THE CUSTOMER PROVIDED THE FOLLOWING INFORMATION ON 11/02/2017, WHEN FOLLOWING UP WITH THE COMPLAINT: "THE SNARE DOES NOT COME OUT OF THE ENDOSCOPE." THE LOT NUMBER W3816721 [DBF-2.4-230-S] WAS PROVIDED PER THE CUSTOMER. THE FOLLOWING WAS RECEIVED ON 11/09/2017 PER THE COOK SALES REPRESENTATIVE: "THE DEVICE INVOLVED WITH THIS COMPLAINT IS NOT A COOK DEVICE." THEREFORE, THE FILE WAS CLOSED UPON CONFIRMATION FROM THE COOK SALES REPRESENTATIVE. A DEVICE MATCHING THE ORIGINALLY REPORTED LOT NUMBER AND REFERENCE PRODUCT NUMBER (RPN) WAS RECEIVED AT COOK ENDOSCOPY AFTER THE FILE WAS CLOSED. ON 12/01/2017, THE DEVICE WAS EVALUATED AND FOUND TO BE UNABLE TO CLOSE UPON HANDLE ACTUATION. THE COOK SALES REPRESENTATIVE REACH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104936 ↗
• MalfunctionDec 11, 2017Failure to Align; Failure to Align

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS IMPOSSIBLE TO BIOPSY WITH THE FORCEPS. THEY DID NOT CUT, "SNATCH/EXTRACT." THEY FINISHED THE PROCEDURE WITH ANOTHER FORCEPS OF THE SAME LOT. THE DEVICE WAS RECEIVED FOR EVALUATION ON 11/16/2017. THE CUPS WERE FOUND TO BE MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104431 ↗
• MalfunctionNov 22, 2017Dull, Blunt; Dull, Blunt

  DURING AN UNKNOWN NUMBER OF ENDOSCOPIC PROCEDURES, THE PHYSICIAN USED COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE PHYSICIAN IS COMPLAINING ABOUT A ¿BATCH OF FORCEPS [2]¿ NOT WORKING PROPERLY. THE NURSE STATES THAT THE PHYSICIAN COMPLAINED LAST WEEK OF THEM [THE FORCEPS DEVICES] PULLING AND NOT CUTTING THE TISSUE, CAUSING HEMATOMA. THE FORCEPS ARE TEARING THE TISSUE INSTEAD OF MAKING A CLEAN CUT WHEN THE ENDOSCOPE IS TORQUED.

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

  MAUDE report 7052609 ↗
• MalfunctionAug 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FOLLOWING WAS REPORTED BY THE CUSTOMER: "WHEN TAKING A DUODENAL BIOPSY, THE MECHANISM GAVE WAY AND A CLICKING NOISE WAS HEARD. WE WERE UNABLE TO RETRIEVE THE SPECIMEN FROM THE FORCEPS AND HAD TO UNDERTAKE ADDITIONAL BIOPSIES WITH A NEW FORCEPS. I HAVE NOT ENCOUNTERED THIS PROBLEM BEFORE. THE FORCEPS WERE BEING USED CORRECTLY AT THE TIME AND NO UNDUE PRESSURE HAD BEEN APPLIED TO THEM."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6795444 ↗
• MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE PHYSICIAN REPORTED THAT THE FORCEPS HAD A LOOSE METAL TIP OF THE CATHETER [METAL TIP OF CATHETER WAS LOOSE] AND THE HANDLE WAS HARD NOT ALLOWING TO OPEN AND CLOSE THE FORCEPS. THE PHYSICIAN NOTICED THE DEFECT AS SOON AS HE OPENED THE PACKAGE. THE BIOPSY FORCEPS WERE NOT INTRODUCED THROUGH THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6585654 ↗
• MalfunctionApr 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A GASTROSCOPY PROCEDURE, THE PHYSICIAN USED A CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE ENDOSCOPIST WAS USING A GASTROSCOPE AND PASSED THE FORCEPS DOWN ENDOSCOPE TO OBTAIN A SPECIMEN. WHEN THE BIOPSY FORCEPS WERE OPENED, THEY WOULD NOT CLOSE PROPERLY. THE GASTROSCOPE HAD TO BE REMOVED FROM PATIENT AS THE FORCEP WOULD NOT CLOSE (SUBJECT OF THIS REPORT). THE GREY SHEATH COATING ON THE BIOPSY FORCEP WAS DAMAGED AND THE WIRE COILING WAS EXPOSED. SHE ALSO MENTIONED THAT THIS HAPPENED A FEW WEEKS AGO [SEE RELATED MDR 1037905-2017-00195].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6511778 ↗