Captura G31585Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00827002315853), received between Mar 1, 2016 and Feb 28, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2020Failure to Align; Difficult to Open or Close; Failure to Align; Difficult to Open or Close

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USE A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE DISPOSABLE BIOPSY FORCEPS (DBF) CUPS WOULD NOT CLOSE. 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 9770784 ↗
• MalfunctionFeb 3, 2020Difficult to Open or Close; Difficult to Open or Close

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. WHEN USED, IT WAS FOUND THAT THE BIOPSY FORCEPS WERE BROKEN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. NEW INFORMATION WAS RECEIVED ON 08-JAN-2020 STATING THAT THE HANDLE BROKE AND CUPS WERE UNABLE TO CLOSE. 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 9662080 ↗
• MalfunctionAug 17, 2018Failure to Align; Failure to Align

  IN PREPARATION FOR A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THEY OPENED THE PACKAGE AND CHECKED THE DEVICE AND FOUND THE TIP OF THE CUP IS NOT STRAIGHT [FORCEPS HEAD BENT], SO THEY USE ANOTHER NEW DEVICE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 26-JULY-2018 AND IT WAS DETERMINED THAT THE CUPS DO NOT LINE UP PROPERLY WHEN IN THE CLOSED POSITION.

  Patient problems: No Patient Involvement

  MAUDE report 7792665 ↗
• MalfunctionSep 29, 2017Failure to Align; Material Protrusion/Extrusion; Failure to Align; Material Protrusion/Extrusion

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE PHYSICIAN WANTED TO TAKE A BIOPSY IN THE GASTROINTESTINAL TRACT, BUT AS THE PHYSICIAN PUSHED THE FORCEPS THROUGH THE SCOPE, IT GOT STUCK AND DAMAGED THE SCOPE DUE TO THE FACT THAT THE FORCEPS SPIKE WAS STICKING OUT ON THE SIDE OF THE FORCEPS. THIS DEVICE WAS EVALUATED ON 09/06/2017, AND THE CUPS WERE FOUND TO BE POTENTIALLY MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6904101 ↗
• MalfunctionJul 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. AFTER OPENING, THE BRANCHES [FORCEPS CUPS] WOULD NOT CLOSE ANYMORE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6735315 ↗
• MalfunctionJun 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. AS REPORTED TO CUSTOMER RELATIONS, "THE FORCEPS WERE PUT INTO THE ENDOSCOPE. IT WAS OPENED AND WOULD NOT CLOSE. THE COMPLAINT DEVICE WAS REMOVED AND A NEW DBF-2.4-230SP-S WAS OPENED AND USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6670794 ↗
• MalfunctionJun 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURE BIOPSY FORCEPS WITH SPIKE. THE PRODUCT NUMBER FOR THE DEFECTIVE BIOPSY FORCEPS WITH SPIKE IS DBF-2.4-230SP-S, LOT W3843715. THE FORCEPS THAT WERE CUT WOULD NOT CLOSE AND GOT STUCK OUTSIDE THE TIP OF THE ENDOSCOPE. THE PROCEDURE HAD TO BE TERMINATED FOR FEAR OF PERFORATION OF THE PATIENT'S COLON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6666791 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE FORCEPS WOULD NOT STAY CLOSED. THE HANDLE BROKE AND THEY WERE NOT ABLE TO OPEN IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591705 ↗
• MalfunctionMay 25, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE FORCEP WOULD NOT STAY CLOSED. THE HANDLE BROKE AND THEY WERE NOT ABLE TO OPEN IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6591701 ↗
• MalfunctionMay 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE FOLLOWING WAS REPORTED ON (B)(6) 2017 PER THE COOK SALES REPRESENTATIVE: DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE CUSTOMER HAS HAD A COUPLE OF ISSUES WITH OUR FORCEPS THIS WEEK. I DON'T KNOW THE NATURE OF THESE ISSUES YET. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. UPDATED INFORMATION WAS OBTAINED FROM THE CUSTOMER ON (B)(6) 2017: "THE PHYSICIAN ADVANCED THE DEVICE THROUGH THE ENDOSCOPE AND AFTER THE FORCEPS WERE OPEN, IT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6573038 ↗
• MalfunctionApr 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. WHEN THEY OPENED THE FORCEPS TO PERFORM THE BIOPSY, THE CUPS DID NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529403 ↗
• MalfunctionApr 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLIC BIOPSY [STOMACH ULCER] PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE PHYSICIAN INTRODUCED THE FORCEPS INTO THE OPERATING CHANNEL OF THE ENDOSCOPE. THE OPENING OF THE FORCEPS WAS OKAY, BUT IT WAS IMPOSSIBLE TO CLOSE THEM. THE HANDLE COULD MOVE BUT HAD NO ACTION ON THE CLOSING OF THE FORCEPS. IT WAS POSSIBLE TO CLOSE THE FORCEPS BY PULLING ON THE HUB AND THUS RETRIEVAL FROM THE OPERATING CHANNEL. ANOTHER FORCEPS WAS USED TO PERFORM THE BIOPSY. THERE WERE NO CLINICAL CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6517071 ↗
• MalfunctionApr 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE FOLLOWING WAS REPORTED ON 04/10/2017: DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE DRIVE CABLE BROKE AT THE CUP [LINK WIRE TO DRIVE WITH SOLDER JOINT BREAKS]. THE FOLLOWING WAS RECEIVED 04/21/2017: THE USER WAS UNABLE TO OPEN OR CLOSE THE FORCEPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6478514 ↗
• MalfunctionApr 4, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. UPON CLOSING THE DEVICE, IT SNAPPED AND WOULD NO LONGER FUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6458070 ↗
• MalfunctionMar 1, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITH SPIKE. THE DEVICE TORE THE TISSUE INSTEAD OF TAKING A BITE. IT WAS NOT A CLEAN BITE. IT DID NOT CAUSE EXCESSIVE BLEEDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5471135 ↗