Captura Pro G47686Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002476868), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.

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.

• InjuryFeb 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING UPPER GASTROINTESTINAL BIOPSY PROCEDURES, THE PHYSICIAN USED AT LEAST TWO (2) CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. THE CUSTOMER WAS CONCERNED WITH THE AMOUNT OF "BITE" TAKEN IN THE BIOPSY AND FEELS THAT IT WAS CAUSING MORE BLEEDING THAN IT SHOULD AND WAS REQUIRING CLIPPING THAT SHOULD NOT BE REQUIRED. ADDITIONAL INFORMATION PROVIDED BY THE COOK DISTRICT MANAGER ON 06-FEB-2019: ALL CASES WERE UPPER GASTROINTESTINAL CASES, ESOPHAGEAL (FROM TOP TO BOTTOM) AND GASTRIC BIOPSIES. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THESE EVENTS, BUT ADDITIONAL CLIPS WERE BEING USED BEYOND WHAT CUSTOMER EXPECTS TO HAVE TO USE. A SECTION OF THE DEVICES DID NOT REMAIN INSIDE THE PATIENTS' BODY. THE PATIENTS REQUIRED MORE THAN EXPECTED HEMOSTASIS CLIPPING DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Hemostasis; No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 8361371 ↗