Captura Pro G47697Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002476974), received between Jan 11, 2019 and Jan 11, 2019 — classified as 1 malfunction.

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 11, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. THE PHYSICIAN COMMENTED TO THE COOK SALES DISTRICT MANAGER THAT IT [THE FORCEPS] WAS TAKING TOO BIG OF A BITE. BECAUSE THE BITE WAS SO BIG, IT WAS CAUSING A HEMOTAOMA IN THE MUCOSA. THE PHYSICIAN WILL BE TRYING THE 2.2 MM CUP SIZE AS IT IS A SMALLER CUP SIZE. 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: Hematoma; Tissue Damage

  MAUDE report 8241472 ↗