Captura G31577Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002315778), received between Apr 27, 2017 and Feb 11, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2025Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close

  DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE FORCEPS WOULD NOT OPEN OR CLOSE. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE PRELIMINARY QE EVALUATION OF THE DEVICE SHOWS THE FORCEPS CUPS WERE STUCK IN A HALF OPEN POSITION. 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 21354319 ↗
• MalfunctionFeb 11, 2025Difficult to Open or Close; Difficult to Open or Close

  DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS WOULD NOT OPEN OR CLOSE. THE FORCEPS HEAD WAS BENT SEVERELY TO ONE SIDE. 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 21352121 ↗
• MalfunctionFeb 7, 2025Nonstandard Device; Difficult to Open or Close; Material Twisted/Bent; Nonstandard Device; Difficult to Open or Close; Material Twisted/Bent

  DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GASTRIC BIOPSY PROCEDURE AND THE FORCEPS WOULD NOT OPEN OR CLOSE AFTER BEING INSERTED INTO THE ENDOSCOPE. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE PRELIMINARY QE EVALUATION OF THE DEVICE SHOWS THE FORCEPS HEAD LINK WIRE IS BROKEN. 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 21336024 ↗
• MalfunctionJan 22, 2025Difficult to Open or Close; Difficult to Open or Close

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GASTRIC BIOPSY PROCEDURE, IN WHICH A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE, WAS USED. IT WAS REPORTED THAT THE FORCEPS WOULD NOT OPEN OR CLOSE AFTER BEING INSERTED INTO THE ENDOSCOPE HAD TO BE BROKEN IN ORDER TO REMOVE IT. IT WAS NOT POSSIBLE TO TAKE A BIOPSY. 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 21207696 ↗
• MalfunctionDec 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A TISSUE BIOPSY OF A GASTRIC EROSION SITE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE PHYSICIAN DETECTED THAT HALF OF THE CUP DETACHED IN THE PATIENT AND CANNOT FIND THE MISSING PART IN PATIENT. USER THEN CHANGED TO ANOTHER OF THE SAME DEVICE AND A SUFFICIENT NUMBER OF SAMPLES WERE FINALLY OBTAINED. ONE HALF OF THE FORCEPS CUP/JAW DETACHED AND REMAINED INSIDE THE PATIENT¿S BODY TO PASS NATURALLY. 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: Foreign Body In Patient

  MAUDE report 18355360 ↗
• MalfunctionDec 28, 2021Difficult to Open or Close; Difficult to Open or Close

  DURING AN UPPER DIGESTIVE ENDOSCOPY (UDE) WITH BIOPSY IN THE STOMACH, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE FORCEPS DID NOT OPEN AND CLOSE AS EXPECTED DURING 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 13101514 ↗
• MalfunctionMar 1, 2021Difficult to Open or Close; Material Twisted/Bent; Difficult to Open or Close; Material Twisted/Bent

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE PHYSICIAN PERFORMED THE FIRST BIOPSY SUCCESSFULLY. BUT, WHEN HE TRIED TO PERFORM A NEW COLLECTION THE FORCEPS DAMAGED ITS OPENING MECHANISM NEXT TO THE FORCEPS SHELL, PREVENTING ITS USE FOR COLLECTION A NEW FRAGMENT [SIC]. THREE IMAGES WERE PROVIDED FOR INVESTIGATION. THE IMAGES SHOWED A GAP IN-BETWEEN THE CUPS [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 11393253 ↗
• MalfunctionOct 29, 2019Failure to Align; Failure to Align

  PRIOR TO AN ESOPHAGUS ENDOSCOPY PROCEDURE, THE PHYSICIAN UNCOVERED A CAPTURA BIOPSY FORCEPS WITHOUT SPIKE BUT OBSERVED THE DEVICE HAD A DEFECT OF MISALIGNMENT. THIS DEFECT WAS EVIDENT WHEN THE FORCEPS WERE DISSEMBLED [UNPACKAGED]. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9252646 ↗
• MalfunctionOct 25, 2019Failure to Align; Failure to Align

  PRIOR TO AN ESOPHAGUS ENDOSCOPY PROCEDURE, THE PHYSICIAN UNCOVERED A CAPTURA BIOPSY FORCEPS WITHOUT SPIKE BUT OBSERVED THE DEVICE HAD A DEFECT OF MISALIGNMENT. THIS DEFECT WAS EVIDENT WHEN THE FORCEPS WERE DISSEMBLED [UNPACKAGED]. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 9240919 ↗
• MalfunctionOct 25, 2019Failure to Align; Failure to Align

  PRIOR TO AN ESOPHAGUS ENDOSCOPY PROCEDURE, THE PHYSICIAN UNCOVERED A CAPTURA BIOPSY FORCEPS WITHOUT SPIKE BUT OBSERVED THE DEVICE HAD A DEFECT OF MISALIGNMENT. THIS DEFECT WAS EVIDENT WHEN THE FORCEPS WERE DISSEMBLED [UNPACKAGED]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9240916 ↗
• MalfunctionJun 10, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN CHOSE A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE USER REPORTS THAT, AT THE TIME OF OPENING THE NEW PACKAGE, THEY SAW THE DISTAL TIP OF THE BIOPSY CLAMP [CUPS] THAT WAS NOT STRAIGHT [TIP IS BENT AT FORK ARM]. [WHEN TESTING] THE MECHANISM FOR OPENING AND CLOSING, [THEY HAD] DIFFICULTY. THERE WAS NO COMPLICATION TO THE PATIENT. THERE WAS NO PART OF THE DEVICE [DETACHED] INSIDE THE PATIENT. THEY DECIDED TO NOT USE THE BIOPSY FORCEPS. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON 16-MAY-2019 THE DEVICE WAS RECEIVED FOR EVALUATION. IT WAS OBSERVED THAT THE CUPS ARE 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 8684575 ↗
• MalfunctionNov 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. ACCORDING TO THE DOCTOR'S REPORT, THE FORCEPS BROKE DURING THE PROCEDURE AND CANNOT BE USED. A VIDEO OF THE DEVICE WAS PROVIDED, WHICH DEMONSTRATED THAT THE FORCEPS CUPS WILL OPEN, BUT THEY WILL NOT CLOSE UPON HANDLE MANIPULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7024198 ↗
• MalfunctionNov 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. ACCORDING TO THE DOCTOR'S REPORT, " THE CLAMP CATHETER WAS DRILLED AND CAN NOT BE USED." A VIDEO OF THE DEVICE WAS PROVIDED, WHICH DEMONSTRATED THAT THE FORCEPS CUPS WILL OPEN, BUT THEY WILL NOT CLOSE UPON HANDLE MANIPULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7024196 ↗
• MalfunctionJun 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE USER FOUND THAT THE FORCEPS COULD NOT OPEN AND CLOSE WHEN THEY TRIED TO ADVANCE THEM INTO THE ENDOSCOPE CHANNEL. THEY REPLACED IT WITH A NEW DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6658429 ↗
• MalfunctionJun 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED THREE (3) COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE USER FOUND THAT THE FORCEPS COULD NOT OPEN AND CLOSE WHEN THEY TRIED TO ADVANCE THEM INTO THE ENDOSCOPE CHANNEL. THEY REPLACED THEM WITH NEW DEVICES TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6658427 ↗
• MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A GASTRIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. AFTER PASSING THROUGH THE WORK CHANNEL TO PERFORM THE GASTRIC BIOPSY, THE FORCEPS WERE OPENED FOR COLLECTION OF THE MATERIAL AND NO LONGER CLOSED, EVEN WITH THE OPENING AND CLOSING MOVEMENT. THE FORCEPS WERE KEPT OPEN, AND THE ENDOSCOPE WAS REMOVED [FROM THE PATIENT] TO REMOVE THE FORCEPS FROM THE WORKING CHANNEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6585897 ↗
• MalfunctionApr 27, 2017Off-Label Use; Device Operates Differently Than Expected; Off-Label Use; Device Operates Differently Than Expected

  DURING A BRONCHOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURE BIOPSY FORCEPS WITHOUT SPIKE [OFF LABEL USE]. THE FORCEPS WERE DEFECTIVE SHORTLY AFTER THE BIOPSY. THE FORCEPS WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525513 ↗