Captura G53630Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002536302), received between Oct 27, 2017 and Oct 27, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Align” (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.

• MalfunctionOct 27, 2017Failure to Align; Failure to Align

  DURING A GASTROSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - NO SPIKE. THE CUSTOMER STATED THAT WHILE DOING A GASTROSCOPY, THE BIOPSY FORCEPS DAMAGED THE ENDOSCOPE. THE DEVICE WAS EVALUATED ON 10/03/2017. THE CUPS WERE FOUND TO BE POTENTIALLY MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985264 ↗