Captura Pro G47698Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002476981), received between Dec 16, 2019 and Jan 13, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (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.

• MalfunctionJan 13, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  DURING A GASTROSCOPY IN THE STOMACH AND DUODENUM, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE FORCEPS "BREAK DOWN" WHEN THE NURSE OPENED IT [DEVICE] TO TAKE THE BIOPSY [SAMPLE] OUT. THIS OCCURRED OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 16161313 ↗
• MalfunctionJan 13, 2023Difficult to Open or Close; Difficult to Open or Close

  DURING A GASTROSCOPY FOR BIOPSY IN THE STOMACH AND DUODENUM, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE GRIPPER [FORCEPS] LACKED GRIP STRENGTH FROM THE BEGINNING AND WAS DEFORMED, UNABLE TO COLLECT A BIOPSY SAMPLE. IT WAS IMPOSSIBLE TO TAKE OUT THE BIOPSY THAT WAS DONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 16160971 ↗
• MalfunctionDec 16, 2019Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITHOUT SPIKE. WHEN THE CUSTOMER PUT THE PRODUCT DOWN THE CHANNEL OF THE ENDOSCOPE, AND WENT TO OPEN THE DEVICE, ONE OF THE CUPS WAS LYING FLAT AND BROKEN. ONE OF THE WIRES APPEARS TO NOT BE ACTIVATING [ACTUATING THE CUPS, ONLY ONE CUP WILL ACTUATE]. THE CUSTOMER GENTLY PULLED DEVICE BACK TO CLOSE THE DEVICE, PULLED IT OUT OF THE ENDOSCOPE, AND USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THEY TESTED IT OUTSIDE THE PATIENT BUT IT DID NOT WORK OUTSIDE THE PATIENT EITHER. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 20-NOV-2019 AND FOUND 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 9477358 ↗