Captura G56076Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00827002560765), received between Feb 7, 2017 and Mar 19, 2020 — classified as 2 injuries, 58 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (47 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 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2020Failure to Align; Failure to Align

  DURING A GASTRIC BIOPSY PROCEDURE, THE PHYSICIAN USED COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE PRODUCT WAS "DEFECTIVE". INFORMATION WAS RECEIVED ON 03/09/2020, PER THE CC FORM, THAT THE FORCEPS WOULD NOT OPEN. ANOTHER SET OF FORCEPS WERE USED TO COMPLETE THE PROCEDURE. ON 25-FEBRUARY-2020, THE DEVICE WAS RETURNED AND DETERMINED 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 9856512 ↗
• MalfunctionDec 3, 2018Difficult to Open or Close; Difficult to Open or Close

  DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. IT INITIALLY WORKED FINE. UPON THE FOURTH PASS THROUGH THE ENDOSCOPE, IT OPENED BUT WOULD NOT CLOSE. THE CUSTOMER SAID THAT IT FELT AS IF SOMETHING HAD BROKEN IN THE HANDLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. 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 8125967 ↗
• MalfunctionOct 26, 2018Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. PER THE CUSTOMER, "WHEN THEY WERE TAKING BIOPSIES OF THE GASTRO-ESOPHAGEAL (GE) JUNCTION AND THEY WERE PULLING THE FORCEPS OUT OF THE ENDOSCOPE, THEY FELT RESISTANCE. IT APPEARED THAT THE HINGE WAS STICKING OUT OF THE HOUSING A LITTLE BIT. PRIOR TO THIS INCIDENT, THEY HAD TAKEN SMALL BOWEL BIOPSIES AND GASTRIC BIOPSIES BUT THEY DID NOT NOTICE A PROBLEM UNTIL THEY WERE TRYING TO PULL FORCEPS OUT OF THE ENDOSCOPE AFTER GE JUNCTION BIOPSIES. THEY NOTICED THAT SOMETHING WAS STICKING OUT OF THE HOUSING BEFORE THEY DID THE GE JUNCTION BIOPSIES. ALL INTENDED BIOPSIES WERE SUCCESSFULLY COMPLETED WITH THIS DEVICE." THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 01-OCT-2018 AND IT WAS DETERMINED THAT THE FORCEPS CUPS WERE 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 8009666 ↗
• MalfunctionSep 25, 2018Difficult to Open or Close; Difficult to Open or Close

  DURING A COLONIC BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THEY COULD NOT ADVANCE THE DEVICE INTO THE COLONOSCOPE. A NEW ONE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 11-SEPTEMBER-2018 AND THE FORCEPS CUPS WERE DETERMINED TO BE UNABLE TO FULLY 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 7905722 ↗
• MalfunctionSep 13, 2018Dull, Blunt; Dull, Blunt

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE DEVICE RIPPED THE SURROUNDING TISSUE. THE PATIENT MIGHT HAVE HAD A TISSUE ISSUE. THE TISSUE WAS MORE FRIABLE. THERE WAS MORE BLEEDING THAN NORMAL. SEVEN (7) TOTAL BIOPSIES WERE TAKEN. FOUR (4) BIOPSIES RIPPED THE TISSUE. 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; Tissue Damage

  MAUDE report 7873687 ↗
• MalfunctionSep 11, 2018Solder Joint Fracture; Difficult to Open or Close; Solder Joint Fracture; Difficult to Open or Close

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP- SPIKE. ONCE DOWN THE ENDOSCOPE, THE FORCEPS WOULD NOT OPEN. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS EVALUATED ON 17-AUGUST-2018 AND WAS FOUND TO BE ABLE TO OPEN, BUT THE CUPS WOULD NOT CLOSE UPON HANDLE MANIPULATION. 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 7864243 ↗
• MalfunctionSep 7, 2018Dull, Blunt; Dull, Blunt

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. THE USERS WERE TAKING A BIOPSY IN THE ASCENDING COLON AND THE PATIENT HAD A THREE (3) MM POLYP. WHEN THE FORCEPS BIT FOR THE SAMPLE, IT RIPPED THE SURROUNDING TISSUE WHEN THE BITE CAME UP. 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; Tissue Damage

  MAUDE report 7855568 ↗
• MalfunctionJul 30, 2018Break; Break

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP- SPIKE. THE CUSTOMER TOOK ONE (1) BIOPSY. WHEN THEY WENT DOWN [THE ENDOSCOPE] FOR THE SECOND BIOPSY AND CLAMPED DOWN ON THE MUCOSA, THE JAWS OF THE FORCEPS BROKE. THE COOK SALES REPRESENTATIVE BELIEVED THAT ONE (1) OF THE DRIVE WIRES BROKE AT THE CUP (DISTAL) END OF THE FORCEPS, AND DISCONNECTED. THEY USED ANOTHER FORCEPS SUCCESSFULLY TO COMPLETE PROCEDURE. 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 7732235 ↗
• MalfunctionJun 18, 2018Dull, Blunt; Device Operates Differently Than Expected; Dull, Blunt; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED COOK CAPTURA SERRATED FORCEPS WITH SPIKE. THE FORCEPS ARE TAKING TOO DEEP OF BITES (SUBJECT OF THIS REPORT). THE FOLLOWING WAS REPORTED ON (B)(6) 2018: "IT [TEARING AND BLEEDING] WAS NOTICED IN BOTH THE COLON AND ESOPHAGUS. DEEP BITES WERE NEEDED FOR BARRETS [ESOPHAGEAL CONDITION]. THE BITES WERE TOO BIG ON COLITIS [COLON INFLAMMATION] SURVEILLANCE AND CAUSED BLEEDING. SCREENING COLONOSCOPIES WITH BIOPSIES CAUSED EXCESSIVE BLEEDING AND SOME PATIENTS HAD TO COME BACK TO GET CLIPPED [CLIP APPLICATION FOR HEMOSTASIS]. THIS HAPPENED TO FOUR (4) PATIENTS WITHIN A TWO (2) WEEK SPAN, NONE OF WHICH WHO WERE ON ANTICOAGULANTS (SUBJECT OF THIS REPORT, AND SEE RELATED MDR1037905-2018-00261, MDR 1037905-2018-00262)." UPDATED INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 15-JUNE-2018: "ALL CASES WERE USED WITH THE COOK SL FORCEPS. FOUR (4) PATIENTS WERE CLIPPED PROPHYLACTICALLY [AS A PREVENTIVE MEASURE] (SUBJECT OF THIS REPORT) AFTER TWO (2) PATIENTS WERE PREVIOUSLY ADMITTED TO THE HOSPITAL (SEE RELATED MDRS 1037905-2018-00261 AND RELATED MDR 1037905-2018-00262). THE FIRST PATIENT ADMITTED REQUIRED A TRANSFUSION (MDR 1037905-2018-00261) AND TH

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 7612105 ↗
• InjuryJun 18, 2018Dull, Blunt; Device Operates Differently Than Expected; Dull, Blunt; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. THE CUSTOMER REPORTED THAT THEY HAD A PATIENT COME BACK WITH A GASTROINTESTINAL BLEED [POST PROCEDURE WHERE FORCEPS WERE USED] (SUBJECT OF THIS REPORT). THE FOLLOWING WAS REPORTED ON 01-JUNE 2-018: "IT [TEARING AND BLEEDING] WAS NOTICED IN BOTH THE COLON AND ESOPHAGUS. DEEP BITES WERE NEEDED FOR BARRETS [ESOPHAGEAL CONDITION]. THE BITES WERE TOO BIG ON COLITIS [COLON INFLAMMATION] SURVEILLANCE AND CAUSED BLEEDING. SCREENING COLONOSCOPIES WITH BIOPSIES CAUSED EXCESSIVE BLEEDING AND SOME PATIENTS HAD TO COME BACK TO GET CLIPPED [CLIP APPLICATION FOR HEMOSTASIS]. THIS HAPPENED TO FOUR (4) PATIENTS WITHIN A TWO (2) WEEK SPAN, NONE OF WHICH WHO WERE ON ANTICOAGULANTS (SUBJECT OF THIS REPORT, AND SEE RELATED MDR1037905-2018-00262, MDR 1037905-2018-00263)." UPDATED INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 15-JUNE-2018: "ALL CASES WERE USED WITH THE COOK SL FORCEPS. FOUR (4) PATIENTS WERE CLIPPED PROPHYLACTICALLY [AS A PREVENTIVE MEASURE] (SEE RELATED MDR 1037905-2018-00263) AFTER TWO (2) PATIENTS WERE PREVIOUSLY ADMITTED TO THE HOSPITAL (SUBJECT OF THIS REPORT AND RELATED MDR 1037905-2018-0

  Patient problems: Blood Loss; Hemostasis

  MAUDE report 7612104 ↗
• InjuryJun 18, 2018Dull, Blunt; Device Operates Differently Than Expected; Dull, Blunt; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. THE FORCEPS ARE TAKING TOO DEEP OF BITES (SUBJECT OF THIS REPORT). THE FOLLOWING WAS REPORTED ON 01-JUNE-2018: "IT [TEARING AND BLEEDING] WAS NOTICED IN BOTH THE COLON AND ESOPHAGUS. DEEP BITES WERE NEEDED FOR BARRETS [ESOPHAGEAL CONDITION]. THE BITES WERE TOO BIG ON COLITIS [COLON INFLAMMATION] SURVEILLANCE AND CAUSED BLEEDING. SCREENING COLONOSCOPIES WITH BIOPSIES CAUSED EXCESSIVE BLEEDING AND SOME PATIENTS HAD TO COME BACK TO GET CLIPPED [CLIP APPLICATION FOR HEMOSTASIS]. THIS HAPPENED TO FOUR (4) PATIENTS WITHIN A TWO (2) WEEK SPAN, NONE OF WHICH WHO WERE ON ANTICOAGULANTS (SUBJECT OF THIS REPORT, AND SEE RELATED MDR1037905-2018-00261, MDR 1037905-2018-00263)." UPDATED INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON 15-JUNE-2018: "ALL CASES WERE USED WITH THE COOK SL FORCEPS. FOUR (4) PATIENTS WERE CLIPPED PROPHYLACTICALLY [AS A PREVENTIVE MEASURE] (SEE RELATED MDR 1037905-2018-00263) AFTER TWO (2) PATIENTS WERE PREVIOUSLY ADMITTED TO THE HOSPITAL (SUBJECT OF THIS REPORT AND RELATED MDR 1037905-2018-00261). THE FIRST PATIENT ADMITTED REQUIRED A TRANSFUSION (SEE RELATED MDR 1037905-2018-

  Patient problems: Tissue Damage

  MAUDE report 7612101 ↗
• MalfunctionApr 27, 2018Dull, Blunt; Dull, Blunt

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED NINE (9) CAPTURA SERRATED LARGE FORCEP-SPIKES. THE NINE (9) FORCEPS MALFUNCTIONED DURING THE PROCEDURE. WHEN THEY WERE TRYING TO ACQUIRE THE TISSUE, THEY WERE RIPPING THE TISSUE INSTEAD OF CUTTING THE TISSUE. ALL NINE (9) WERE USED IN THIS SAME PROCEDURE. A TENTH DEVICE FROM A DIFFERENT LOT NUMBER WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 7467878 ↗
• MalfunctionJan 30, 2018Bent; Failure to Align; Bent; Failure to Align

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. ONE OF THE CUPS WAS NOTED TO BE BENT ONCE REMOVED FROM THE ENDOSCOPE AFTER THE FIRST PASS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7228242 ↗
• MalfunctionJan 15, 2018Failure to Align; Failure to Align

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP - SPIKE. WHEN THEY WENT TO OPEN THE FORCEPS, THE CUPS OPENED UP IN AN "L" SHAPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 12/21/2017 AND IT WAS OBSERVED THAT THE FORCEPS CUPS WERE POTENTIALLY MISALIGNED. THEY ALSO HAD A GAP IN THE CUPS WHEN IN THE CLOSED POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7191982 ↗
• MalfunctionDec 29, 2017Use of Device Problem; Device Operates Differently Than Expected; Use of Device Problem; Device Operates Differently Than Expected

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATED TO THIS EVENT. PLEASE REFERENCE THE ADDITIONAL MANUFACTURER NARRATIVE FOR THIS JUSTIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7155386 ↗
• MalfunctionOct 17, 2017Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE FORCEPS WOULD NOT OPEN. THE DEVICE WAS TESTED PRIOR TO THE PROCEDURE AND WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO HARM TO THE PATIENT." THE DEVICE WAS EVALUATED ON 09/25/2017. THE DEVICE WAS FOUND TO BE POTENTIALLY MISALIGNED DUE TO THE SHEATH PROTRUDING OVER THE CUPS.

  Patient problems: No Patient Involvement

  MAUDE report 6954962 ↗
• MalfunctionAug 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. WHEN TAKING THE BIOPSY, [THE FORCEPS] PULLED ALL THE SURROUNDING TISSUE AND DID NOT BITE THE TISSUE FROM THE ACTUAL SITE. THERE WERE NO ADVERSE EVENTS, BUT IT [THE PROCEDURE] DID NOT GO AS PLANNED. THE DEVICE WAS EVALUATED ON 08/09/2017. THE CUPS OF THE FORCEPS WERE FOUND TO BE POTENTIALLY MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6829675 ↗
• MalfunctionJul 21, 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. THE HANDLE BROKE. THE FOLLOWING INFORMATION WAS RECEIVED 07/1/2017: "STAFF SAID THAT SOMETHING INSIDE THE HANDLE BROKE AND THEY WERE UNABLE TO OPEN THE FORCEP." THE DEVICE WAS EVALUATED ON 07/14/2017. IT WAS FOUND TO OPEN, BUT NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6732036 ↗
• MalfunctionJul 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE FORCEPS WERE PUT DOWN THE ENDOSCOPE AND WOULD NOT OPEN. THE FORCEPS WERE REMOVED AND WOULD OPEN OUTSIDE THE COLONOSCOPE. ANOTHER FORCEPS WAS PULLED TO USE TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATED AT COOK ON 06/28/2017. DURING THE EVALUATION, THE FORCEPS WERE UNABLE TO CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6713597 ↗
• MalfunctionJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN UPPER ENDOSCOPY, THE PHYSICIAN USED TWO (2) COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE DEVICE WAS PLACED DOWN THE ENDOSCOPE IN THE STOMACH AND BIOPSIES WERE TO BE OBTAINED; HOWEVER, THE FORCEPS OPENED BUT WOULD NOT CLOSE. THE EVENT OCCURRED TWO TIMES IN A ROW. THE ENDOSCOPE HAD TO BE REMOVED OUT OF THE PATIENT AND FORCEPS MANUALLY CLOSED TO BE REMOVED FROM THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6711313 ↗
• MalfunctionJul 13, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN UPPER ENDOSCOPY PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA SERRATED LARGE FORCEP-SPIKE. THE DEVICE WAS PLACED DOWN THE ENDOSCOPE IN THE STOMACH, AND BIOPSIES WERE TO BE OBTAINED; HOWEVER, THE FORCEPS OPENED BUT WOULD NOT CLOSE. THE EVENT OCCURRED TWO TIMES IN A ROW. THE ENDOSCOPE HAD TO BE REMOVED OUT OF THE PATIENT AND FORCEPS MANUALLY CLOSED TO BE REMOVED FROM THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710225 ↗
• MalfunctionJul 10, 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 LARGE FORCEP - SPIKE. THE FORCEPS OPENED AND THEN WOULD NOT CLOSE AFTER PLACED DOWN THE ENDOSCOPE. THE FORCEPS WERE SHAKEN AND THEY STILL WOULD NOT CLOSE. THE PHYSICIAN REMOVED THE FORCEPS FROM THE ENDOSCOPE AND USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6698328 ↗
• MalfunctionJun 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A CAPTURA SERRATED LARGE FORCEPS-SPIKE. THEY TOOK ONE BITE. WHEN THEY WENT BACK DOWN FOR ANOTHER SAMPLE, THE FORCEPS WOULD OPEN BUT WOULD NOT CLOSE. AT THAT POINT, THEY FELT SOMETHING SNAP IN THE HANDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6680129 ↗
• MalfunctionJun 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE COOK AREA REPRESENTATIVE BASED ON COMMENTS MADE BY THE USER: THE FORCEPS OPENED THEN WOULD NOT CLOSE AFTER THE FORCEPS WERE INSIDE THE ENDOSCOPE. THE FORCEPS HANDLE WAS SHAKEN AND STILL UNABLE TO CLOSE. THE PHYSICIAN FORCIBLY REMOVED [THE DEVICE] FROM THE ENDOSCOPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6657850 ↗
• MalfunctionJun 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA SERRATED LARGE FORCEPS-SPIKE. THE DEVICE WAS "BROKEN". THE DEVICE WAS RECEIVED FOR EVALUATION ON 05/30/2017. THE CUPS WERE FOUND TO BE POTENTIALLY MISALIGNED. ON 06/13/2017, THE SUPPLIER EVALUATION CONFIRMED THAT THE CUPS WERE MISALIGNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654879 ↗