Captura G56133Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00827002561335), received between Apr 4, 2017 and Dec 14, 2017 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (43 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE WAS BROKEN. IT APPEARS THAT THE FORCEPS WOULD NOT CLOSE. THE DEVICE WAS RECEIVED FOR EVALUATION ON (B)(6) 2017. IT WAS FOUND THAT THE CUPS WERE MISALIGNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7119014 ↗
• MalfunctionOct 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A CAPTURA SERRATED FORCEPS WITH SPIKE. AFTER TAKING A PIECE OF TISSUE, THEY WERE NOT ABLE TO PULL FORCEPS OUT OF THE ENDOSCOPE. THEY HAD TO REMOVE THE ENTIRE ENDOSCOPE WITH THE FORCEPS AND CUT OFF THE TIP OF THE FORCEPS AND THEN REMOVED THE REST OF THE DEVICE FROM THE ENDOSCOPE. THE FOLLOWING WAS CONFIRMED BY THE SALES REPRESENTATIVE ON 10/26/2017: THE USER FELT AS IF THEY COULD NOT REMOVE THE FORCEPS FROM THE ENDOSCOPE BECAUSE THEY WOULD NOT CLOSE, THEREFORE THEY REMOVED THE ENTIRE ENDOSCOPE FROM THE PATIENT AND CUT THE FORCEPS TO REMOVE THEM FROM THE ENDOSCOPE CHANNEL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983246 ↗
• MalfunctionOct 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DOCTOR WENT DOWN THE FUJI ENDOSCOPE WITH THE DEVICE. UPON OPENING FORCEPS, THEY WERE HARD TO OPEN AND THEN WOULD NOT CLOSE. THE DOCTOR PULLED THE FORCEPS OUT OF THE ENDOSCOPE AND NOTICED A CABLE STICKING OUT OF THE FORCEPS. THIS EVENT CAUSED INTERNAL DAMAGE OF THE DISTAL TIP OF BIOPSY ENDOSCOPE CHANNEL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT FORCEPS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6983245 ↗
• MalfunctionOct 2, 2017Failure to Align; Failure to Align

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A CAPTURA SERRATED FORCEPS WITH SPIKE. AS REPORTED TO CUSTOMER RELATIONS: "THE FORCEPS DID NOT OBTAIN THE SPECIMEN." THE DEVICE WAS EVALUATED ON 9/7/2017 AND IT WAS OBSERVED THAT THE FORCEPS CUPS WERE POTENTIALLY MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6908644 ↗
• MalfunctionSep 29, 2017Failure to Align; Failure to Align

  DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. AS REPORTED TO CUSTOMER RELATIONS: "THE DM [DISTRICT MANAGER] CALLED STATING SHE WAS AT THIS FACILITY AND WAS HANDED A BAG OF DEVICES TO BE RETURNED TO COOK. SOME OF THE DEVICE FAILURES DATE BACK TO (B)(6) OF 2017 AND THE CAUSE OF THE DIFFICULTY IS UNKNOWN AND CANNOT BE OBTAINED." THE DEVICE WAS EVALUATED ON 9/6/17 AND IT WAS OBSERVED THAT THE FORCEPS CUPS WERE POTENTIALLY MISALIGNED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6905044 ↗
• MalfunctionSep 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A CAPTURA SERRATED FORCEPS WITH SPIKE. AS REPORTED TO CUSTOMER RELATIONS: "DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE THE FORCEPS WERE ADVANCED DOWN AN OLYMPUS ENDOSCOPE AND OPENED. WHEN THE PHYSICIAN WENT TO CLOSE THE FORCEPS THEY WOULD NOT CLOSE. THE SCOPE HAD TO BE REMOVED IN ORDER TO REMOVE THE FORCEPS. THERE WAS NO HARM TO THE PATIENT AND ANOTHER OF THE SAME FORCEPS WAS USED TO COMPLETE THE PROCEDURE." THE DEVICE WAS EVALUATED ON 9/6/17 AND IT WAS OBSERVED DURING EVALUATION THAT THE FORCEPS CUPS WOULD OPEN BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6887969 ↗
• MalfunctionAug 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A CAPTURA BIOPSY FORCEPS WITH SPIKE. THEY HEARD A POP AND THE DEVICE WOULD NO LONGER OPEN OR CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6802125 ↗
• MalfunctionAug 16, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN SELECTED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WOULD NOT OPEN WHEN TESTING BEFORE THE PROCEDURE. THE DEVICE WAS EVALUATED ON 07/26/2017. IT WOULD OPEN, BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6798084 ↗
• MalfunctionJul 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE BIOPSY FORCEPS BROKE AT THE HANDLE. THE FORCEPS WOULD NOT CLOSE SO THE ASSISTANT HAD TO CUT THE HANDLE TO GET THE CUPS TO CLOSE SO THE FORCEPS COULD BE REMOVED FROM THE ENDOSCOPE. THEY TRIED TO MANIPULATE THE DRIVE WIRE AFTER CUTTING BUT IT WOULD NOT CLOSE THE FORCEPS CUPS. THE PHYSICIAN PULLED OUT THE ENDOSCOPE AND THE FORCEPS. THE PROCEDURE WAS FINISHED WITHOUT TAKING A BIOPSY BECAUSE THEY DECIDED IT WAS NOT NECESSARY, AND THE PATIENT'S CONDITION WAS SOMEWHAT COMPROMISED (FROM THEIR ILLNESS-NOT THE FORCEPS, PER PHYSICIAN) SO THEY DECIDED TO STOP THE CASE AFTER REMOVING THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6748283 ↗
• MalfunctionJul 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THEY WENT TO TAKE A BIOPSY. THE HANDLE SNAPPED AND IT WOULD NO LONGER OPEN OR CLOSE. THE DEVICE WAS EVALUATED ON 06/30/2017. IT WAS FOUND THAT THE CUPS OF THE FORCEPS WERE MISSING. THE FOLLOWING CLARIFICATION WAS RECEIVED ON 07/06/2017 PER THE CUSTOMER: THE FORCEPS WERE REMOVED STUCK IN THE OPEN POSITION FROM THE PATIENT WITH THE ENDOSCOPE. ONCE IT WAS OUTSIDE THE BODY, IT WAS CUT OFF TO BE ABLE TO PASS THROUGH THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697738 ↗
• MalfunctionJul 10, 2017Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE WAS PLACED DOWN THE ENDOSCOPE. THE USER OPENED IT AND THEY COULD NOT GET IT TO CLOSE. THEY REMOVED IT AND USED ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697678 ↗
• MalfunctionJul 7, 2017Solder Joint Fracture; Device Operates Differently Than Expected; Solder Joint Fracture; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE WAS DEFECTIVE; UNKNOWN EVENT DESCRIPTION. THE DEVICE WAS RECEIVED FOR EVALUATION ON 6/14/2017: THE DEVICE WAS TESTED AND THE FORCEPS WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6693086 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN GASTROSCOPY PROCEDURE, THE PHYSICIAN USED FOUR (4) COOK CAPTURA SERRATED FORCEPS WITH SPIKE. DURING THE PROCEDURE THEY FELT SOMETHING SNAP AND THE FORCEPS WOULD NOT OPEN OR CLOSE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680196 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN GASTROSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. DURING THE PROCEDURE THEY FELT SOMETHING SNAP AND THE FORCEPS WOULD NOT OPEN OR CLOSE. ANOTHER DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680192 ↗
• MalfunctionJun 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE DEVICE DID NOT CLOSE ONCE IT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6678935 ↗
• MalfunctionJun 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE PHYSICIAN COULD NOT CLOSE THE FORCEPS AND WITHDREW THE COLONOSCOPE FROM THE PATIENT. WHEN THE FORCEPS WERE REMOVED FROM THE COLONOSCOPE, IT WAS NOTED THE HEAD OF THE FORCEPS WERE BROKEN. THE PHYSICIAN NOTED THAT NOTHING DETACHED INSIDE OF THE PATIENT AND THERE WAS NO PATIENT HARM. THEY USED A SECOND FORCEPS TO CONTINUE THE PROCEDURE WITH NO FURTHER DIFFICULTIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6678902 ↗
• MalfunctionJun 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS DID NOT CLOSE WHILE DOWN THE ENDOSCOPE INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6658470 ↗
• MalfunctionJun 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THEY PUT THE DEVICE DOWN THE ENDOSCOPE. THEY WENT TO TAKE A SAMPLE AND IT POPPED AND WOULD NO LONGER OPEN OR CLOSE. THE POP FELT LIKE THE POP THAT IS EXPERIENCED WHEN DEPLOYING A HEMOSTASIS CLIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6654271 ↗
• MalfunctionJun 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE USER WAS UNABLE TO CLOSE [THE FORCEPS].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6644954 ↗
• MalfunctionJun 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. "DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN DID ONE BIOPSY AND WAS ATTEMPTING TO TAKE THE SECOND. WHEN THE FORCEPS WERE OPENED SOMETHING SNAPPED AND THE FORCEPS WOULD NOT CLOSE. [THE DEVICE] WAS REMOVED FROM THE ENDOSCOPE IN AN OPENED POSITION AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6639674 ↗
• MalfunctionJun 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. "DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN DID ONE BIOPSY AND WAS ATTEMPTING TO TAKE THE SECOND. WHEN THE FORCEPS WERE OPENED SOMETHING SNAPPED AND THE FORCEPS WOULD NOT CLOSE. [THE DEVICE] WAS REMOVED FROM THE ENDOSCOPE IN AN OPENED POSITION AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6639671 ↗
• MalfunctionJun 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IN PREPARATION FOR A ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED THREE (3) COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WERE TESTED AND THE DEVICES BROKE AT THE HANDLE. THEY WOULD NOT OPEN NOR CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6623753 ↗
• MalfunctionJun 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. AFTER ONE BITE [BIOPSY], THE FORCEPS SNAPPED. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608642 ↗
• MalfunctionJun 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE (EITHER AN ESOPHAGOGASTRODUODENOSCOPY (EGD) OR COLONOSCOPY), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608563 ↗
• MalfunctionJun 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE (EITHER AN ESOPHAGOGASTRODUODENOSCOPY (EGD) OR COLONOSCOPY), THE PHYSICIAN USED A COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6608548 ↗