Captura G56052Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002560529), received between Jan 5, 2018 and Jan 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-NO SPIKE. THE DEVICE WAS USED FOR BIOPSY FOR THE LESION IN THE LARGE INTESTINE. THE CUPS DID NOT OPEN IN THE TARGET SITE. THEREFORE, ANOTHER DEVICE FROM THE SAME LOT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS EVALUATED ON 12/11/2017, AND IT WAS DETERMINED THAT THE CUPS WOULD OPEN, BUT NOT CLOSE UPON HANDLE MANIPULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169763 ↗