Captura G56071Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002560710), received between Apr 28, 2017 and Oct 25, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2019Solder Joint Fracture; Failure to Align; Solder Joint Fracture; Failure to Align

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE DEVICE WAS REPORTED TO HAVE A SHARP PIECE OUT OF THE BIOPSY CUP [SPIKE PROTRUDING FROM CUPS]. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED WHEN THE DEVICE WAS EVALUATED [ON 01/OCT/2019] NOTING THE CUPS WERE POTENTIALLY 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 9240989 ↗
• MalfunctionFeb 15, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING A GASTROSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE BIOPSY FORCEPS WAS NOT WORKING. A PHOTO FROM THE CUSTOMER WAS RECEIVED ON 21-JAN-2019 THAT DEPICTS ONE SIDE OF THE FORCEPS CUPS STUCK OPEN. THE DEVICE WAS EVALUATED ON 31-JAN-2019 AND THE COILED SHEATH WAS CUT AT THE DISTAL END OF THE DEVICE. THE SPIKE WAS ALSO DETACHED FROM THE FORCEP. ONE OF THE CUPS WAS HANGING FROM THE HOUSING. THE FOLLOWING WAS RECEIVED 06-FEB-2019: THEY WERE NOT ABLE TO PULL THE BIOPSY FORCEPS BACK IN THE ENDOSCOPE SO THEY HAD TO REMOVE THE ENDOSCOPE WITH THE BIOPSY FORCEPS OUT OF THE PATIENT. BECAUSE OF THAT THE BROKEN CUPS OF THE BIOPSY FORCEPS DAMAGED THE ESOPHAGUS. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 12-FEB-2019 FROM THE AREA REPRESENTATIVE: DUE TO THE OPEN CUP FROM THE FORCEPS, THE FORCEPS HIT THE WALL OF THE ESOPHAGUS A LITTLE BIT. BUT, IT WAS NOT AS BAD AS THEY TOLD ME AT FIRST. NO TREATMENT WAS PERFORMED. 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 OCCURR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8342635 ↗
• MalfunctionAug 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A CAPTURA BIOPSY FORCEPS WITH SPIKE. [THE] WIRE WHICH CONNECTS HANDLE AND FORCEPS MECHANISM SNAPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803932 ↗
• MalfunctionAug 18, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) CAPTURA BIOPSY FORCEPS WITH SPIKE. [THE] WIRE WHICH CONNECTS HANDLE AND FORCEPS MECHANISM SNAPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6803931 ↗
• MalfunctionApr 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A GASTROSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE FORCEPS WERE TESTED BEFORE THE INTRODUCTION IN THE CHANNEL OF THE ENDOSCOPE. AT THE TIME OF THE BIOPSY AND CLOSING THE FORCEPS, A BREAKING NOISE OCCURRED AND THE NURSE WAS UNABLE TO CLOSE THE CUP. THE DOCTOR HAS THE RETRIEVE [REMOVE] THE ENDOSCOPE FROM THE PATIENT IN ORDER TO CLOSE THE CUP OF THE BIOPSY FORCEPS. THEY USED A NEW BIOPSY FORCEPS TO MAKE THE BIOPSIES AND FINISH THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529641 ↗