Captura Pro G47690Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002476905), received between May 12, 2021 and May 28, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2021Difficult to Open or Close; Difficult to Open or Close

  DURING A COLONOSCOPY, THE PHYSICIAN USED THREE (3) COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS DID NOT CLOSE AND THE DRIVE WIRE WAS EXPOSED. THE FORCEPS WERE CHANGED OUT TO FINISH THE PROCEDURE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11901121 ↗
• InjuryMay 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS BROKE WHICH RESULTED IN A RETAINED PIECE OF THE METAL FORCEPS THAT THEY HAD TO THEN GO IN AND RETRIEVE WITH ANOTHER FORCEPS. NO HARM WAS DONE TO THE PATIENT DURING THIS INCIDENT. A SECTION OF THE DEVICE INITIALLY DETACHED BUT WAS RETRIEVED AND 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: Foreign Body In Patient

  MAUDE report 11847765 ↗
• MalfunctionMay 12, 2021Break; Detachment of Device or Device Component; Difficult to Open or Close; No Apparent Adverse Event; Break; Detachment of Device or Device Component; Difficult to Open or Close; No Apparent Adverse Event

  DURING A COLONOSCOPY , THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE. THE WHOLE TIP OF THE BIOPSY FORCEPS CAME APART. THE SCOPE WAS WITHDRAWN FROM THE PATIENT AND THE FORCEPS WERE CAREFULLY REMOVED AND EXAMINED TO MAKE SURE ALL PARTS WERE ACCOUNTED FOR. THE SCOPE WAS THEN RE-ADVANCED AND NEW FORCEPS WERE USED TO TAKE BIOPSIES. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATION ON 15 APRIL 2021 AND IT WAS DETERMINED THE FORCEPS CUPS WOULD NOT CLOSE [SUBJECT OF THE REPORT]. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11813082 ↗