Captura G56132Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002561328), received between May 16, 2017 and May 14, 2019 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE BIOPSY FORCEPS BROKE DURING THE FIRST SAMPLING [BIOPSY]. IT WAS IMPOSSIBLE TO CLOSE THE FORCEPS AGAIN. THEY HAD TO STOP THE GASTROSCOPY TO REMOVE THE FORCEPS. 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; No Known Impact Or Consequence To Patient

  MAUDE report 8609565 ↗
• MalfunctionNov 2, 2018Failure to Align; Failure to Align

  DURING A DUODENAL BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. PER THE CUSTOMER, "WE HAVE A HUGE PROBLEM. I BELIEVE THERE IS AN ISSUE WITH YOUR FORCEPS. WE HAVE TWO ENDOSCOPES WITH LEAKS. TODAY WHEN USING THE ENDOSCOPE AND FORCEPS, WE NOTICED WE WERE UNABLE TO PULL THE FORCEPS OUT AND IT IS DUE TO THIS TINY METAL PIECE STICKING OUT EVEN WHEN THE FORCEPS ARE CLAMPED SHUT. WE HAVE HAD IN THE PAST AN OUTRAGEOUS AMOUNT OF REPAIRS NEEDED ON OUR SCOPES." THE PHOTO DEPICTS THE SPIKE ARM PROTRUDING THROUGH THE CUP HOUSING. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 11-OCT-2018 AND THE FORCEPS CUPS WERE FOUND TO BE 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 8033727 ↗
• MalfunctionJun 12, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE USER HEARD A SNAP IN THE HANDLE AND THE FORCEPS NO LONGER OPENED OR CLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633207 ↗
• MalfunctionMay 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN SELECTED A CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WOULD NOT OPEN WHEN TESTED DURING PREPARATION. THE DEVICE DID NOT MAKE PATIENT CONTACT. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER FORCEPS. ON 05/04/2017, THE DEVICE WAS RECEIVED FOR EVALUATION. IT WAS FOUND THAT THE JAWS WOULD OPEN BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593798 ↗
• MalfunctionMay 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE CUPS WOULD NOT OPEN NOR CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6585463 ↗
• MalfunctionMay 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. WHEN THEY WERE TAKING THE FIRST BIOPSY, THERE WAS A SNAP IN THE HANDLE AND IT WOULD NOT OPEN. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 04/21/2017. THE FORCEPS CUPS WERE FOUND BE TO ABLE TO OPEN, BUT UNABLE TO CLOSE [SUBJECT OF THIS REPORT].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6569009 ↗
• MalfunctionMay 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. WHEN THEY WERE TAKING THE FIRST BIOPSY, THERE WAS A SNAP IN THE HANDLE AND IT WOULD NOT OPEN. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 04/21/2017. THE FORCEPS CUPS WERE FOUND BE TO ABLE TO OPEN, BUT UNABLE TO CLOSE [SUBJECT OF THIS REPORT].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6569007 ↗