Captura G53006Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00827002530065), received between Apr 25, 2017 and Dec 30, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Difficult to Open or Close; Difficult to Open or Close

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT WHEN PERFORMING A BIOPSY DURING A GASTROSCOPY WITH A NASOGASTROSCOPE, THE FORCEPS OPENS AND CLOSES BUT IT REVEALS A SMALL METAL ROD IN THE IMAGE. WHEN ATTEMPTING TO RAISE THE CLAMP IN THE OPERATOR CHANNEL, IT WAS IMPOSSIBLE TO RAISE THE CLAMP. THE ENDOSCOPE WAS CAREFULLY REMOVED SO AS NOT TO INJURE THE PATIENT WITH THE INSTRUMENT [UNABLE TO REMOVE FORCEPS FROM ENDOSCOPE - 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23922294 ↗
• MalfunctionAug 9, 2024Difficult to Open or Close; Difficult to Open or Close

  DURING AN UNKNOWN PROCEDURE, THE USER SELECTED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT IT FELT LIKE THE DRIVE WIRE OF THE COMPLAINT DEVICE BROKE AND WOULD NOT OPEN/CLOSE APPROPRIATELY. THE PROCEDURE WAS FINISHED WITH THE ANOTHER OF THE SAME DEVICE BUT DIFFERENT LOT NUMBER. 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 19951201 ↗
• MalfunctionAug 8, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close

  DURING A BRONCHOSCOPY, THE USER SELECTED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT IT SOUNDED LIKE SOMETHING SNAPPED AND MECHANICAL MECHANISM WAS DAMAGED THAT THE FORCEPS WOULD NOT FUNCTION, WOULD NOT OPEN/CLOSE APPROPRIATELY. THIS OCCURRED OUTSIDE OF THE BODY AS THEY ALWAYS CHECK DEVICES BEFORE THEY USE THEM. THE PROCEDURE WAS FINISHED WITH THE ANOTHER OF THE SAME DEVICE BUT DIFFERENT LOT NUMBER. 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 19944798 ↗
• MalfunctionJul 16, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT THESE TWO FORCEPS BROKE DURING PROCEDURES TODAY. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RETURNED ON 21JUN2024 FOR EVALUATION. THE QUALITY ENGINEERING INITIAL ASSESSMENT STATED THAT THE DEVICE RETURNED WITH THE CUPS OPENED AND WOULD NOT CLOSE WHEN HANDLE WAS MANIPULATED. 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 19749811 ↗
• MalfunctionJul 16, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT TWO FORCEPS BROKE DURING PROCEDURES. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RETURNED ON 21JUN2024 FOR EVALUATION. THE QUALITY ENGINEERING INITIAL ASSESSMENT STATED THAT THE DEVICE RETURNED WITH THE CUPS OPENED AND WOULD NOT CLOSE WHEN HANDLE WAS MANIPULATED. 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 19749804 ↗
• MalfunctionJun 12, 2023Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE FORCEPS TO OBTAIN A BIOPSY WHEN HE NOTICED THE END OF THE DEVICE DISCONNECTED TO THE CATHETER. THE FORCEPS WAS REMOVED FROM PATIENT AND REPLACED WITH A NEW ONE. NO BODY WAS INJURED AND NO OTHER ISSUES. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON (B)(6)2023, AND OUR INITIAL QE EVALUATION SHOWS THE DRIVE WIRE IS BROKEN ON ONE OF THE JAWS AND THE CUPS REMAIN OPEN AND ARE UNABLE TO BE CLOSED [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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17108868 ↗
• MalfunctionDec 14, 2020Failure to Align; Failure to Align

  IN PREPARATION FOR A GASTRIC BIOPSY, THE USER PREPARED THE CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE USER REPORTED THAT THEY OPENED THE PACKAGE AND FOUND THE CUP WAS "BENT" PRIOR TO PATIENT CONTACT. A PHOTO WAS PROVIDED AND DEPICTS A GAP IN THE TEETH WHEN THE CUP IS CLOSED [SUBJECT OF THIS REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 11002846 ↗
• MalfunctionDec 12, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE PHYSICIAN ATTEMPTED A PERORAL GASTRIC BIOPSY, BUT A MALFUNCTION OF THE CUPS PROHIBITED HIM TO DO THAT. THE BIOPSY WAS NOT COMPLETED BUT THE PROCEDURE WAS FINISHED. THIS EVENT WAS NOT REPORTABLE AT THE TIME. CLARIFICATION WAS RECEIVED ON 15-NOV-2019 NOTING THAT THE MALFUNCTION OF THE CUPS MEANT THE CUPS COULD BE OPENED BUT WHILE ATTEMPTING TO CLOSE THE CUPS, THE CUPS COULD NOT BE 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 9457578 ↗
• MalfunctionOct 22, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING A GASTROINTESTINAL TRACT BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O [WITHOUT] SPIKE. WHEN THE FORCEPS WERE INSERTED INTO THE TARGET SITE FOR THE BIOPSY, THE CUPS COULD BE OPENED BUT COULD NOT BE CLOSED. THEREFORE, THE DEVICE WAS REMOVED WITH THE ENDOSCOPE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED ON 28/OCT/2019 FROM THE CUSTOMER, NOTED, "AFTER THE ISSUE OCCURRED, THE PHYSICIAN CANCELLED THE BIOPSY. AFTERWARD, HE CLOSED THE FORCEPS BY HAND AND REMOVED IT FROM THE ENDOSCOPE. THE FORCEPS COULD NOT BE CLOSED BY THE HANDLE OPERATION." 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 9221547 ↗
• MalfunctionAug 23, 2019Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE DEVICE WAS USED FOR STOMACH BIOPSY WITH A TRANSNASAL ENDOSCOPE. THOUGH THE USER ATTEMPTED TO PERFORM BIOPSY OF THE LESION IN THE STOMACH WITH THE DEVICE, THE CUPS DID NOT OPEN OR CLOSE PROPERLY. THE CUPS WOULD OPEN AND CLOSE ENOUGH TO BE REMOVED FROM THE ENDOSCOPE, BUT THEY WERE SLOW TO OPEN AND CLOSE. THEREFORE, ANOTHER OF THE SAME DEVICE AND LOT NUMBER WAS USED INSTEAD. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 05-AUG-2019 AND FOUND TO HAVE A GAP IN THE FORCEPS 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 8927832 ↗
• MalfunctionJul 20, 2018Material Integrity Problem; Material Integrity Problem

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE BIOPSY WAS PERFORMED WITH THE CAPTURA DEVICE IN THE STOMACH. HOWEVER, BECAUSE ONE OF THE FORCEPS CUPS DID NOT CLOSE, THE BIOPSIED SPECIMEN WAS NOT INSIDE THE CUPS WHEN THE DEVICE WAS REMOVED THROUGH THE ENDOSCOPE. ANOTHER DEVICE, LIKELY TO BE THE SAME PRODUCT FROM ANOTHER LOT, WAS USED INSTEAD 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 Consequences Or Impact To Patient

  MAUDE report 7706106 ↗
• MalfunctionMay 3, 2018Device Operates Differently Than Expected; Device-Device Incompatibility; Device Operates Differently Than Expected; Device-Device Incompatibility

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE FORCEPS WERE NOT OPENING SYMMETRICALLY AND ONLY CLOSING PARTIALLY. THEY DID NOT COME OUT OF THE OPERATING CHANNEL DURING A NASOGASTROSCOPY WITHOUT GENERAL ANESTHESIA. THE FORCEPS WERE TAKEN OUT [OF THE NASOGASTROSCOPE] AT THE END OF THE PROCEDURE WHEN THE NASOGSATROSCOPE WAS OUT OF THE PATIENT. ONLY ONE BIOPSY WAS DONE OUT OF THREE [INTENDED BIOPSIES]. PER THE CUSTOMER, THERE WAS A RISK OF DAMAGING THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7484608 ↗
• MalfunctionSep 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE USER CONFIRMED THAT THE CUPS COULD OPEN AND CLOSE DURING A FUNCTIONAL TEST AFTER OPENING THE PACKAGE. THE USER THEN INSERTED THE FORCEPS INTO THE ENDOSCOPE ACCESSORY CHANNEL AND ATTEMPTED TO OPEN THE CUPS AT THE TARGET SITE, BUT THE CUPS WOULD NOT OPEN. ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE DEVICE WAS EVALUATED ON 08/30/2017. THIS DEVICE WAS RETURNED WITH THE CUPS OPEN AND THEY WILL NOT CLOSE. THE CUPS ARE BENT AND APPEAR TO HAVE A LINK WIRE BENT AND BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885837 ↗
• MalfunctionJun 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC BIOPSY IN THE STOMACH, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. THE CUPS COULD NOT BE CLOSED AT THE STOMACH DURING PROCEDURE. TO PERFORM FIRST BIOPSY, THE USER OPENED THE CUPS, HOWEVER, IT WAS IMPOSSIBLE TO MANIPULATE WHEN SHE ATTEMPTED TO CLOSE [THE CUPS]. SHE FELT THAT SHE HEARD A SNAPPING SOUND WHEN THE CUPS OPENED. TO REMOVE THE DEVICE, THE USER CUT THE PROXIMAL SIDE OF THE SHEATH, BUT THE CUPS WOULD NOT CLOSE, THEREFORE THE DEVICE AND ENDOSCOPE WERE REMOVED FROM THE PATIENT'S BODY TOGETHER. ANOTHER DEVICE OF THE SAME LOT NUMBER WAS USED TO COMPLETE THE PROCEDURE WITHOUT PROBLEMS. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6658632 ↗
• MalfunctionApr 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN UPPER ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE WOULD NOT CLOSE AND HAD TO BE REMOVED WITH THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525656 ↗
• MalfunctionApr 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. AT THE END OF THE PROCEDURE, THE FORCEPS WERE USED TO TAKE SOME AMPULLARY BIOPSIES AND OPERATED IT IN A NORMAL FASHION. THEY USED IT TWO TIMES TAKING TWO BITES EACH TIME AND THEN THE FORCEPS HANDLE BROKE ON THE THIRD PASS. THEY HAD GOTTEN ENOUGH SAMPLES SO THEY FINISHED THE PROCEDURE. ON 03/31/2017, AN EVALUATION RESPONSE LETTER WAS RECEIVED FROM THE APPROVED SUPPLIER. THE SUPPLIER EVALUATION FOUND THAT THE LINK WIRE TO DRIVE WIRE SOLDER JOINT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6520383 ↗