Captura ProRecalls & reported problems across all models
Cook Incorporated · 15 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 15 models of Captura Pro by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 67 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2018 and Jul 10, 2026 — classified as 9 injuries, 58 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Captura Pro problems
Device problems
- Difficult to Open or Close35
- Failure to Align14
- Detachment of Device or Device Component10
- Break9
- Fracture9
- Component Misassembled6
- Dull, Blunt4
- Nonstandard Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient25
- No Patient Involvement8
- Tissue Damage4
- Foreign Body In Patient3
- Hemostasis3
- Device Embedded In Tissue or Plaque1
- Gastrointestinal Hemorrhage1
Captura Pro models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Captura Pro G50697Endoscopic grasping/cutting instrument, non-powered, exempt17 reports
- Captura Pro G47693Endoscopic grasping/cutting instrument, non-powered, exempt12 reports
- Captura Pro G47692Endoscopic grasping/cutting instrument, non-powered, exempt9 reports
- Captura Pro G50696Endoscopic grasping/cutting instrument, non-powered, exempt8 reports
- Captura Pro G56999Endoscopic grasping/cutting instrument, non-powered, exempt5 reports
- Captura Pro G47690Endoscopic grasping/cutting instrument, non-powered, exempt3 reports
- Captura Pro G47698Endoscopic grasping/cutting instrument, non-powered, exempt3 reports
- Captura Pro G47696Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura Pro G56998Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura Pro G47686Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura Pro G47691Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura Pro G47697Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura Pro G47699Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura Pro G56996Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura Pro G57003Endoscopic grasping/cutting instrument, non-powered, exempt1 report
Recent Captura Pro adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2026Failure to Cut
Patient problems: Laceration(s)
MAUDE report 25781537 ↗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 ↗MalfunctionMar 27, 2025Difficult to Open or Close; Component Misassembled; Difficult to Open or Close; Component Misassembled
DURING AN ENDOSCOPIC PROCEDURE TO TAKE BIOPSY SAMPLES IN THE DUODENUM, THE PHYSICIAN USED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT WHEN THEY WANT TO CLOSE, IT TOOK TIME AND THEY FELT LOT OF RESISTANCE. IT WAS STUCK OPEN. 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 21704558 ↗MalfunctionFeb 7, 2025Difficult to Open or Close; Difficult to Open or Close
DURING AN ENDOSCOPIC PROCEDURE TO TAKE BIOPSY SAMPLES IN THE DUODENUM, THE PHYSICIAN USED 2 COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT ONCE THE FIRST DEVICE HAD PASSED THE CANAL OF THE ENDOSCOPE, IT COULD BE OPENED BUT THEN IT COULD NOT CLOSE. THE SECOND DEVICE COULD OPEN WELL, BUT WHEN THEY WANTED TO CLOSE, IT TOOK TIME AND THEY FELT A LOT OF RESISTANCE. BOTH PRODUCTS WERE USED IN THE SAME 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 21335323 ↗MalfunctionFeb 7, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close
IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO BIOPSY FORCEPS WITH SPIKE, G47693. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PACKAGING IT WAS NOTED TO BE BENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21333647 ↗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 ↗MalfunctionDec 13, 2024Break; Fracture; Difficult to Open or Close; Break; Fracture; Difficult to Open or Close
IN PREPARATION FOR AN UNKNOWN PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THEY NOTICED THAT THE JAWS [FORCEPS CUPS] CAME OFF AND TWO WIRES WERE PRESENT ON THE DEVICE. THE DEVICE DID NOT MAKE PATIENT CONTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT. IN ADDITION, THE PATIENT SUSTAINED NO CLINICAL CONSEQUENCE AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926041 ↗MalfunctionNov 15, 2024Fracture; Nonstandard Device; Detachment of Device or Device Component; Fracture; Nonstandard Device; Detachment of Device or Device Component
DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT PART OF THE PRODUCT BROKE OFF [THE FORCEPS JAW BROKE OFF] OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695713 ↗MalfunctionNov 4, 2024Difficult to Open or Close; Difficult to Open or Close
DURING AN UNKNOWN PROCEDURE, THE PHYSICIAN USED A CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT ONE OF THE DRIVE CABLES BROKE. 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 Clinical Signs, Symptoms or Conditions
MAUDE report 20605039 ↗MalfunctionOct 3, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close
DURING AN UPPER ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THEY MADE MULTIPLE SUCCESSFUL BIOPSIES WITH THIS DEVICE AND THEN LATER IN THE CASE, THE ARM BROKE ON ONE OF THE CUPS. IT IS BARELY ATTACHED TO THE DEVICE. THEY HAD CUT TO CUT THE TIP OFF OF THE DEVICE IN ORDER TO REMOVE IT FROM THE SCOPE. THEY SUCCESSFULLY COMPLETED THE PROCEDURE 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 Clinical Signs, Symptoms or Conditions
MAUDE report 20359104 ↗MalfunctionAug 12, 2024Fracture; Nonstandard Device; Detachment of Device or Device Component; Fracture; Nonstandard Device; Detachment of Device or Device Component
DURING A COLONOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT WHEN THEY WERE TAKING A BIOPSY, ONE OF THE CUPS/JAWS OF THE BIOPSY FORCEPS FELL OFF. THEY WERE ABLE RETRIEVE IT BECAUSE THE CUP WAS SUCTIONED UP AND WAS STUCK TO THE TIP OF THE SCOPE AT THE OPENING OF THE BIOPSY PORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEVICE IN QUESTION AS THIS WAS THE LAST BITE TO REMOVE THE POLYP. 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 19967438 ↗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 ↗MalfunctionApr 10, 2024Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component
IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS INITIALLY REPORTED THAT IT WAS BROKEN RIGHT OUT OF THE PACKAGE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED FOR EVALUATION AND RECEIVED ON 20MAR2024 AND THE CUP HAD DETACHED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19081617 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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