Captura Pro G47699Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002476998), received between Nov 1, 2019 and Nov 1, 2019 — 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.

• MalfunctionNov 1, 2019Failure to Align; Failure to Align

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE. THE PHYSICIAN OBTAINED TWO BIOPSY SAMPLES AND INTRODUCED THE FORCEPS AGAIN TO OBTAIN A THIRD BIOPSY SAMPLE. WHEN ATTEMPTING THE THIRD BIOPSY THE END [JAWS] FLOPPED FORWARD AND WOULD NOT OPEN. THE FORCEPS WERE REMOVED, PLACED ASIDE, AND A SECOND COOK FORCEP WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. THERE WERE NO REPORTABLE INDICATIONS AT THIS TIME. ON (B)(6) 2019, THE DEVICE WAS EVALUATED AND APPEARED 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 9268237 ↗