Captura Pro G50697Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00827002506978), received between Jan 4, 2019 and Jan 26, 2026 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Nonstandard Device; Difficult to Open or Close

  DURING AN ENDOSCOPIC BIOPSY PROCEDURE IN THE COLON, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT WHEN OPENING [FORCEPS] BACK UP FOR BIOPSY, A SNAP OR CLICKING NOISE WAS HEARD. THE FORCEPS WOULD NOT CLOSE [UNABLE TO REMOVE FORCEPS FROM ENDOSCOPE CHANNEL - SUBJECT OF REPORT]. THE SCOPE WAS REMOVED, AND ANOTHER SCOPE WAS USED TO FINISH THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24179066 ↗
• MalfunctionApr 1, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  A PATIENT OF UNSPECIFIED GENDER AND AGE UNDERWENT AN UNSPECIFIED PROCEDURE IN WHICH THE CAPTURA PRO BIOPSY FORCEPS WITH SPIKE WAS USED. IT WAS INITIALLY REPORTED THAT THE PRODUCT MALFUNCTIONED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON 05MAR2025 AND THE INITIAL EVALUATION SHOWED THE FORKS OF THE FORCEPS TIP COMING AWAY FROM THE COIL CABLE. IN ADDITION, DURING A FUNCTIONAL TEST, THE CUPS WOULD ONLY OPEN ON ONE SIDE THEN WOULD NOT MESH TOGETHER WHEN CLOSED AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21740913 ↗
• MalfunctionDec 27, 2024Break; Fracture; Difficult to Open or Close; Break; Fracture; Difficult to Open or Close

  DURING A COLONOSCOPY PROCEDURE IN THE CECUM, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE TIP OF THE FORCEPS BROKE OFF AFTER PUT INTO THE SCOPE. THE DOCTOR WAS UNABLE TO REMOVE THE DEVICE AND HAD TO PULL OUT THE SCOPE WITH THE FORCEPS STICKING OUT THE END OF THE SCOPE. THE REGISTERED NURSE IN THE ROOM TOOK A WIRE CUTTER AND CLIPPED THE END OF THE DEVICE SO IT COULD BE REMOVED FROM THE SCOPE. THIS ADDED TIME TO THE PROCEDURE AND ANESTHESIA WAS LOST. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE BUT HAD TO CUT THE FORCEPS OFF TO REMOVE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21027525 ↗
• MalfunctionJul 19, 2024Difficult to Open or Close; Component Misassembled; Difficult to Open or Close; Component Misassembled

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE PHYSICIAN WENT TO TAKE A BITE (CLOSE) THE FORCEPS TO TAKE A BIOPSY IN THE STOMACH, HEARD A LOUD CLICK, THE FORCEPS WOULD NO LONGER OPEN AND CLOSE. THEY HAD TO REMOVE THE SCOPE AND CLOSE THE FORCEPS BY HAND. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE, NO PATIENT HARM. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19781796 ↗
• MalfunctionMay 24, 2024Fracture; Difficult to Open or Close; Fracture; Difficult to Open or Close

  I PREPARATION FOR AN UNKNOWN PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE HANDLE WAS NOTED TO BE BROKEN UPON OPENING THE PACKAGE. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE USER SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390322 ↗
• MalfunctionSep 14, 2020Difficult to Open or Close; Difficult to Open or Close

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN SELECTED TWO (2) COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. WHEN THE PHYSICIAN TRIED TO TAKE A BIOPSY, THE FORCEPS OPENED OKAY, BUT WHEN THEY TRIED TO CLOSE IT, IT WAS SLUGGISH. THE HANDLE WOULD MOVE LIKE IT WAS CLOSED, BUT THE CUPS OF THE FORCEPS WERE STILL OPEN. A SECOND DEVICE WAS OPENED FROM THE SAME LOT NUMBER; HOWEVER THE VERY SAME DIFFICULTY OCCURRED. A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE WAS OPENED AND USED TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. 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 10527231 ↗
• MalfunctionSep 1, 2020Difficult to Open or Close; Component Misassembled; Difficult to Open or Close; Component Misassembled

  PRIOR TO AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. PREPARING FOR THE PROCEDURE, IT WAS NOTED THAT THE FORCEPS WOULD NOT OPEN/CLOSE. IT SEEMED LIKE THE DRIVEWIRE WAS NOT CONNECTED IN THE HANDLE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10476796 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. AFTER THE BIOPSY THERE WAS A LARGE HEMATOMA AND SOME SLIGHT BLEEDING AT THE SITE. THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP TO STOP THE BLEEDING. NO FURTHER ACTION WAS NEEDED DUE TO THIS OCCURRENCE. THE PHYSICIAN CONFIRMED THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED PLACEMENT OF A HEMOCLIP TO CONTROL THE BLEEDING DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Hemostasis

  MAUDE report 9156485 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. AFTER THE BIOPSY, THERE WAS A LARGE HEMATOMA AND SOME SLIGHT BLEEDING AT THE SITE. THE PHYSICIAN USED A COOK INSTINCT ENDOSCOPIC HEMOCLIP TO STOP THE BLEEDING. NO FURTHER ACTION WAS NEEDED DUE TO THIS OCCURRENCE. THE PHYSICIAN CONFIRMED THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED PLACEMENT OF A HEMOCLIP TO CONTROL THE BLEEDING DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Hemostasis

  MAUDE report 9156453 ↗
• InjuryOct 3, 2019Dull, Blunt; Dull, Blunt

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN WHICH QTY. 1 OF THE CAPTURA PRO BIOPSY FORCEPS WITH SPIKE, G50697, WAS USED. WHEN THE BIOPSY PIECE OF MUCOSA WAS EXTRACTED IT CAUSED APPROXIMATELY A 3-4 CM LACERATION. THE LACERATION BLED VERY LITTLE BIT BUT REQUIRED NO INTERVENTION AS IT TOOK CARE OF ITSELF. BUT THE PHYSICIAN DID INTERVENE AND PLACED A HEMOCLIP JUST IN CASE. THE PHYSICIAN MENTIONED THAT THE PATIENT WAS IN DECLINED HEALTH WHICH MAY HAVE COMPROMISED THE TISSUE INTEGRITY. THE FOLLOWING WAS RECEIVED ON 03 OCTOBER 2019: THE CUSTOMER STATED THAT THE BLEED TOOK CARE OF IT¿S SELF. BUT HE DID PLACE AN INSTINCT CLIP JUST IN CASE, TO REDUCE RISK RE-BLEED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED A CLIP TO BE PLACED DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 9153826 ↗
• MalfunctionJul 25, 2019Failure to Align; Failure to Align

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE [PHYSICIAN] DESCRIBED THAT DURING THE EGD, THE ADVANCEMENT OF THE FORCEPS DID NOT FEEL RIGHT, BUT THEY WERE ABLE TO OBTAIN EIGHT (8) SAMPLES. DURING THE COLONOSCOPY, THE COOK SALES REPRESENTATIVE WAS CALLED INTO THE CASE TO OBSERVE THE DEVICE, AND IT WAS NOTED THAT THE SERRATED PORTION OF THE FORCEPS CUPS WERE NOT LINED UP [MISALIGNMENT]. THE COOK REPRESENTATIVE ADVISED THEM TO SWITCH TO A NEW DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW DEVICE. IT IS UNKNOWN BY THE USER AND COOK REPRESENTATIVE IF THE FORCEPS CUPS WERE MISALIGNED PRIOR TO THE PROCEDURE/ADVANCEMENT DOWN 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 8827800 ↗
• MalfunctionJul 11, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. THE BIOPSY FORCEPS WOULD NOT CLOSE ALL THE WAY WHILE THE PROCEDURE WAS OCCURRING. THEREFORE, THE USER WAS UNABLE TO OBTAIN AN ADEQUATE SPECIMEN. IT WAS ATTEMPTED SEVERAL TIMES TO GET THE FORCEPS TO CLOSE BEFORE ANOTHER ONE WAS OPENED TO COMPLETE THE 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 8781082 ↗
• MalfunctionJul 2, 2019Dull, Blunt; Dull, Blunt

  DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE.THE PHYSICIAN TOOK A BITE AND STATED THAT SOME OF THE TISSUE RIPPED/TORE AS OPPOSED TO THE CLEAN BITE THESE FORCEPS NORMALLY TAKE. 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 8755986 ↗
• MalfunctionApr 24, 2019Difficult to Open or Close; Difficult to Open or Close

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURE PRO¿ BIOPSY FORCEPS WITH SPIKE. THE DEVICE WAS SUCCESSFULLY TESTED PRE-PROCEDURE. THE FORCEPS WERE INSERTED INTO THE ENDOSCOPE. ONE (1) BIOPSY WAS OBTAINED. ON THE SECOND ATTEMPT, ONE (1) OF THE JAWS [FORCEPS CUPS] WOULD NOT CLOSE. THEY REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. WHEN THE DEVICE WAS EVALUATED, IT WAS DETERMINED TO HAVE A MISSING PORTION WHICH MEASURED APPROXIMATELY 1 MM. THE MISSING PORTION WAS NOT RETURNED WITH THE DEVICE. IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER, THE LOCATION OF THE 1MM PORTION OF THE DEVICE IS UNKNOWN. 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: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 8546806 ↗
• MalfunctionMar 22, 2019Failure to Align; Failure to Align

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. AFTER THE THIRD OR FOURTH BITE, THEY COULD NOT PULL THE FORCEPS OUT OF THE ENDOSCOPE. THEY HAD TO CUT THE FORCEPS TO BE ABLE TO REMOVE THE DEVICE. THE ENDOSCOPE AND DEVICE WERE REMOVED TOGETHER AND THE DEVICE WAS CUT OUTSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME FORCEPS. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE PICTURE PROVIDED INDICATES THAT THE FORCEPS WERE IN THE CLOSED POSITION AND THE FORCEPS ARM FORK WAS BROKEN. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 25-FEB-2019 AND IT WAS DETERMINED THAT THE FORCEPS CUPS WERE POTENTIALLY 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 8444266 ↗
• MalfunctionFeb 5, 2019Break; Difficult to Open or Close; Break; Difficult to Open or Close

  DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE PHYSICIAN CHOSE A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, IT WAS NOTED THAT THE JAWS WERE OPENED. IT WAS THEN ALSO NOTED THAT THE HANDLE WAS BROKEN NEAR THE RED NECK AREA. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8305201 ↗
• MalfunctionJan 4, 2019Dull, Blunt; Dull, Blunt

  DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. THE CUSTOMER SAYS IT [FORCEPS] WAS TEARING TISSUE. [THE USER] TOOK A BITE [SAMPLE] IN THE CECUM AND TORE TISSUE DURING THIS PROCESS. 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 8218021 ↗