Captura G56074Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002560741), received between May 17, 2016 and Sep 18, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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.

• MalfunctionSep 18, 2020Device Damaged by Another Device; Difficult to Open or Close; Material Protrusion/Extrusion; Device Damaged by Another Device; Difficult to Open or Close; Material Protrusion/Extrusion

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN SELECTED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. AFTER OPENING THE FORCEPS, IT WAS NOT POSSIBLE TO CLOSE THE CUPS. THE HINGES WERE NOT ALIGNED WITH THE SHAFT OF THE FORCEPS, BUT WERE STICKING OUT. THE FORCEPS COULD NOT BE PULLED BACK INTO THE WORKING CHANNEL OF THE ENDOSCOPE WITHOUT DAMAGING THE ENDOSCOPE. THE COMPLETE ENDOSCOPE PLUS THE FORCEPS WERE TAKEN OUT CAREFULLY. THE OUTSIDE DISTAL PORTION OF THE FORCEPS WAS CUT OFF TO TAKE EVERYTHING OUT OF THE ENDOSCOPE 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 10555604 ↗
• MalfunctionMar 19, 2019Peeled/Delaminated; Improper or Incorrect Procedure or Method; Device Handling Problem; Peeled/Delaminated; Improper or Incorrect Procedure or Method; Device Handling Problem

  DURING AN ENDOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE SHEATH CAME APART [FLAKED OFF] WHILE IT WAS BEING PUT DOWN THE ENDOSCOPE. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. CLARIFICATION WAS RECEIVED 07-MAR-2019 STATING THAT IT WAS PART OF THE GRAY SHEATH ON THE BIOPSY FORCEPS THAT FLAKED OFF. THE PIECE WAS RETRIEVED WITH THE BIOPSY FORCEPS. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE SHEATH WAS FOUND TO BE CRACKED AND MISSING SOME PIECES. 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: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8434237 ↗
• MalfunctionJun 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE FORCEPS WERE ADVANCED DOWN THE ENDOSCOPE. THEY WERE OPENED BUT THEN WOULD NOT CLOSE. THE PHYSICIAN KEPT WORKING WITH THE FORCEPS AND WAS ABLE TO GET THEM CLOSED TO REMOVE FROM THE ENDOSCOPE. ANOTHER OF THE SAME DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT. ON (B)(6) 2017, THE DEVICE WAS RECEIVED FOR EVALUATION. IT WAS FOUND THAT THE JAWS WOULD OPEN BUT WOULD NOT CLOSE AT ALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6623430 ↗
• MalfunctionJun 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE USER OPENED THE FORCEPS AND IT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608524 ↗
• MalfunctionMay 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED THREE (3) COOK CAPTURA FORCEPS WITH SPIKE. THE FORCEPS BROKE WHEN THEY WERE OPENED AND WOULD NOT CLOSE. DURING THE BEGINNING OF THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6538864 ↗
• MalfunctionMay 17, 2016Failure to Align; Failure to Align

  DURING THREE (3) SEPARATE COLONOSCOPY PROCEDURES, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEP WITH SPIKE. THE FORCEP WAS INTRODUCED INTO THE COLONOSCOPE AND WHEN THE ASSISTANT OPENED THE FORCEP, THE DISTAL METAL BIOPSY CUP DETACHED FROM THE SPRING COIL AND EXTENDED ON THE DRIVE WIRE. THE DEVICE WAS REMOVED WITH NO HARM TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. FOUR (4) USED DEVICES FROM THE SAME LOT WERE RETURNED. IT WAS CONFIRMED ON 4/22/16 FROM THE SUPPLIER THAT ONE OF THE DEVICES RETURNED HAD MISALIGNED CUPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5661205 ↗