Captura G56125Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002561250), received between May 25, 2017 and Dec 30, 2021 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2021Off-Label Use; Failure to Cut; Off-Label Use; Failure to Cut

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE IN THE COLON, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. IT WAS REPORTED THAT THE PHYSICIAN DETECTED THERE WAS SLIGHT BLEEDING AFTER THE POLYP OF COLON REMOVAL BY THE FORCEPS. THE PHYSICIAN USED A TITANIUM CLIP TO STOP THE BLEEDING. THE INFORMATION PROVIDED INDICATED THAT THE PHYSICIAN WAS USING THE FORCEPS TO REMOVE A POLYP. THE INTENDED USE STATES, "THIS DEVICE IS USED TO OBTAIN ENDOSCOPIC MUCOSAL TISSUE BIOPSIES AND/OR FOR FOREIGN BODY RETRIEVAL. NOTES: DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. WHILE THE COMPLAINANT DID STATE THAT A TITANIUM CLIP WAS USED TO STOP THE BLEEDING, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 13118126 ↗
• MalfunctionApr 23, 2020Nonstandard Device; Failure to Align; Nonstandard Device; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED THREE (3) COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF CUPS WERE BENT. IT WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON 31MARCH 2020, THE DEVICES WERE EVALUATED AND TWO (2) DEVICES WERE EVALUATED AND FOUND TO BE POTENTIALLY MISALIGNED AND ONE (1) DEVICE THE CUPS WOULD NOT CLOSE FULLY ON ONE SIDE WHEN THE HANDLE WAS HELD IN THE CLOSED POSITION. THE SUPPLIER FOUND THAT ALL THREE (3) DEVICES WERE MISALIGNED (SUBJECT OF REPORT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9990626 ↗
• MalfunctionApr 7, 2020Failure to Align; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF THE DEVICE BENT AND THE CUPS WERE MISPLACED [MISALIGNED]. THERE WAS NO USE ON THE PATIENT. THE PHYSICIAN CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9933381 ↗
• MalfunctionApr 7, 2020Nonstandard Device; Failure to Align; Nonstandard Device; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF THE DEVICE BENT AND THE CUPS WERE MISPLACED [MISALIGNED]. THERE WAS NO USE ON THE PATIENT. THE PHYSICIAN CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9933104 ↗
• MalfunctionApr 7, 2020Nonstandard Device; Failure to Align; Nonstandard Device; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED COOK CAPTURA SERRATED FORCEPS W/O SPIKE. THE PHYSICIAN OPENED THE PACKAGE AND DETECTED THE TIP OF THE DEVICE BENT AND THE CUPS WERE MISPLACED [MISALIGNED]. THERE WAS NO USE ON THE PATIENT. THE PHYSICIAN CHANGED TO ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9933057 ↗
• InjuryJan 29, 2020Failure to Cut; Failure to Cut

  DURING AN ESOPHAGEAL MUCOSAL BIOPSY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. DURING THE PROCEDURE THE FORCEPS MAY NOT HAVE CLAMPED TIGHTLY AND THE ESOPHAGEAL MUCOSA WAS INJURED. A SMALL AMOUNT OF BLEEDING WAS OBSERVED. THE PATIENT WAS THEN TREATED WITH TITANIUM ENDOSCOPIC CLIPS WHICH STOPPED THE BLEEDING. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT WAS TREATED WITH TITANIUM CLIPS TO STOP BLEEDING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Hemostasis; Laceration(s) of Esophagus

  MAUDE report 9641756 ↗
• MalfunctionJul 26, 2019Failure to Align; Failure to Align

  DURING AN UNKNOWN NUMBER OF BIOPSY PROCEDURES, THE PHYSICIAN(S) USED COOK CAPTURA SERRATED FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE ENDOSCOPY SURGEONS ARE HAVING PROBLEMS WITH THE CAPTURA FORCEPS. THEY ARE HAVING TO OPEN TWO (2) TO THREE (3) FORCEPS PER CASE. SOME ARE BENDING AT THE TIP AND SOME HAVE WIRES COMING OUT OF THE TIP ["TROMBONING"]. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE RETURNED AS A REPRESENTATIVE SAMPLE FROM THE USER FACILITY, WAS RECEIVED FOR EVALUATION ON 03-JUL-2019 AND THERE WAS A GAP IN THE FORCEPS CUPS WHEN IN THE CLOSED 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 Consequences Or Impact To Patient

  MAUDE report 8831466 ↗
• MalfunctionAug 18, 2017Device Operates Differently Than Expected; Difficult to Advance; Device Operates Differently Than Expected; Difficult to Advance

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A CAPTURA SERRATED FORCEPS W/O SPIKE. THE FORCEPS GOT STUCK IN THE OPEN POSITION AND BECAME STUCK IN THE ENDOSCOPE WHEN TRYING TO REMOVE. THE FOLLOWING WAS RECEIVED VIA THE CUSTOMER COMPLAINT FORM ON (B)(6) 2017: "FORCEPS INTRODUCED THROUGH BIOPSY PORT, OPENED WHILE ADVANCING. JAMMED OPEN, UNABLE TO REMOVE FORCEPS." FURTHER CLARIFICATION WAS RECEIVED ON THE MALFUNCTION ON 08/18/2017: "THE FORCEPS WERE INSERTED CLOSED, AND OPENED INSIDE THE COLONOSCOPE, BECOMING LOCKED INSIDE THE CHANNEL. IT WAS NOT POSSIBLE TO PULL IT BACKWARD, OR TO EXIT IT FROM THE TIP. THE FORCEPS IS CURRENTLY STUCK INSIDE THE COLONOSCOPE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6805300 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING TWO (2) SEPARATE GASTROSCOPY PROCEDURES, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS W/O SPIKE. BOTH OF THE FORCEPS BROKE. THE PRETEST WAS FINE, BUT THE FORCEPS FAILED TO OPEN WHEN IN USE. THESE CASES WERE IN THE SAME PROCEDURE LIST, BUT IN TWO (2) DIFFERENT CASES. THE DEVICES WERE RECEIVED FOR EVALUATION ON 05/02/2017. IT WAS FOUND THAT THE CUPS WOULD OPEN, BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591334 ↗