Captura G56129Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002561298), received between Aug 29, 2017 and Sep 26, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE WAS USED FOR UPPER ENDOSCOPY. THE PHYSICIAN ATTEMPTED TO OPEN THE CUP AFTER ADVANCING THE DEVICE TO THE TARGET SITE IN THE STOMACH. HOWEVER, BECAUSE THE CUP WOULD NOT OPEN/CLOSE, IT WAS CHANGED WITH ANOTHER COOK CAPTURA SERRATED FORCEPS WITH SPIKE AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE FOLLOWING WAS RECEIVED ON (B)(6) 2017: THE CUPS WOULD NOT OPEN INITIALLY. THE DEVICE WAS EVALUATED ON 09/01/2017. THE CUPS WOULD OPEN, BUT THEY WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6893222 ↗
• MalfunctionAug 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE CUPS DID NOT OPEN OR CLOSE SMOOTHLY WHEN THE CUSTOMER CHECKED DEVICE FUNCTION PRIOR TO PATIENT CONTACT. ANOTHER CAPTURA SERRATED FORCEPS WITH SPIKE WAS USED INSTEAD FOR THE PROCEDURE. THE DEVICE WAS EVALUATED ON 08/08/2017. IT WAS FOUND THAT THE CUPS WOULD OPEN, BUT THEY WOULD NOT CLOSE AT ALL.

  Patient problems: No Patient Involvement

  MAUDE report 6826618 ↗