Captura G56087Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002560871), received between May 8, 2017 and Mar 12, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2019Dull, Blunt; Dull, Blunt

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE FORCEPS DID NOT BITE THROUGH THE TISSUE AND RIPPED [TEARING OF TISSUE]. THE ENDOSCOPIC PICTURE PROVIDED SHOWS BLEEDING AT THE [BIOPSY] SITE. 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: Tissue Damage

  MAUDE report 8413828 ↗
• MalfunctionAug 7, 2018Break; Mechanical Problem; Detachment of Device or Device Component; Break; Mechanical Problem; Detachment of Device or Device Component

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - SPIKE. THE DEVICE BROKE DURING USE WITH NO INJURY TO THE PATIENT. THE JAW ON ONE SIDE WAS DANGLING. OUR ATTEMPTS TO COLLECT SPECIFIC PATIENT OUTCOME INFORMATION WERE UNSUCCESSFUL. BECAUSE THE COMPLAINANT STATED THAT THERE WAS NO INJURY TO THE PATIENT, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7757431 ↗
• MalfunctionMay 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A CAPTURA SERRATED LARGE FORCEP-SPIKE. THE FORCEPS GOT STUCK IN THE OPEN POSITION. THEY FELT LIKE THE HAND MECHANISM BROKE. THE USER WAS EVENTUALLY ABLE TO CLOSE THE FORCEPS AND COMPLETE THE PROCEDURE WITH THIS DEVICE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE DEVICE WAS RECEIVED FOR EVALUATION ON 05/03/2017. IT WAS FOUND THAT THE CUPS OF THE FORCEPS WOULD NOT CLOSE AT ALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6593800 ↗
• MalfunctionMay 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THEY HEARD A LOUD AUDIBLE SNAP AND THEN THE FORCEPS WOULD NO LONGER OPEN OR CLOSE [SUBJECT OF THIS REPORT]. THE CUSTOMER SAID THAT THIS SAME PROBLEM HAD OCCURRED THREE (3) TO FIVE (5) TIMES PRIOR. THE EXACT LOT NUMBERS, QUANTITIES AND EVENT DATES COULD NOT BE CONFIRMED [SEE RELATED MDR 1037905-2017-00276].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6571699 ↗
• MalfunctionMay 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE FORCEPS WERE PUT DOWN THE ENDOSCOPE AND INSIDE THE PATIENT. THE JAWS OPENED AND THEN SOMETHING SNAPPED. THE JAWS WOULD NOT CLOSE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6555680 ↗
• MalfunctionMay 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE TECH REMOVED THE FORCEPS FROM THE PACKAGE, PRETESTED THEM, AND DROPPED [DIPPED THE CUPS] IN SALINE. THE CUPS WERE OPENED AND CLOSED AGAIN AND WHEN CLOSING, THE USER HEARD A "POP" NOISE AND THE HANDLE WOULD NOT CLOSE AND WENT "LIMP".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6551692 ↗