CapturaRecalls & reported problems across all models
Cook Incorporated · 37 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 301
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 37 models of Captura by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 301 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2016 and Dec 30, 2025 — classified as 10 injuries, 291 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (190 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 problems
Device problems
- Device Operates Differently Than Expected190
- Failure to Align50
- Difficult to Open or Close37
- Dull, Blunt11
- Solder Joint Fracture11
- Nonstandard Device10
- Material Twisted/Bent8
- Break6
Patient problems
- No Consequences Or Impact To Patient238
- No Clinical Signs, Symptoms or Conditions21
- No Patient Involvement19
- No Known Impact Or Consequence To Patient15
- Tissue Damage11
- Foreign Body In Patient6
- Gastrointestinal Hemorrhage4
- Hemostasis2
Captura models
37 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Captura G56076Endoscopic grasping/cutting instrument, non-powered, exempt60 reports
- Captura G56133Endoscopic grasping/cutting instrument, non-powered, exempt45 reports
- Captura G31576Endoscopic grasping/cutting instrument, non-powered, exempt19 reports
- Captura G56059Endoscopic grasping/cutting instrument, non-powered, exempt18 reports
- Captura G31577Endoscopic grasping/cutting instrument, non-powered, exempt17 reports
- Captura G53006Endoscopic grasping/cutting instrument, non-powered, exempt16 reports
- Captura G31585Endoscopic grasping/cutting instrument, non-powered, exempt15 reports
- Captura G31583FORCEPS, BIOPSY, ELECTRIC13 reports
- Captura G56125Endoscopic grasping/cutting instrument, non-powered, exempt9 reports
- Captura G56135FORCEPS, BIOPSY, ELECTRIC8 reports
- Captura G56132Endoscopic grasping/cutting instrument, non-powered, exempt7 reports
- Captura G56074Endoscopic grasping/cutting instrument, non-powered, exempt6 reports
- Captura G56087Endoscopic grasping/cutting instrument, non-powered, exempt6 reports
- Captura G56131Endoscopic grasping/cutting instrument, non-powered, exempt6 reports
- Captura G47742BRONCHOSCOPE (FLEXIBLE OR RIGID)5 reports
- Captura G56071Endoscopic grasping/cutting instrument, non-powered, exempt5 reports
- Captura G32727DISLODGER, STONE, BASKET, URETERAL, METAL4 reports
- Captura G53641Endoscopic grasping/cutting instrument, non-powered, exempt4 reports
- Captura G56060Endoscopic grasping/cutting instrument, non-powered, exempt4 reports
- Captura G56126Endoscopic grasping/cutting instrument, non-powered, exempt4 reports
- Captura G53633Endoscopic grasping/cutting instrument, non-powered, exempt3 reports
- Captura G53638Endoscopic grasping/cutting instrument, non-powered, exempt3 reports
- Captura G56061Endoscopic grasping/cutting instrument, non-powered, exempt3 reports
- Captura G56724Endoscopic grasping/cutting instrument, non-powered, exempt3 reports
- Captura G53042Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura G53642Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura G54170Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura G56073Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura G56129Endoscopic grasping/cutting instrument, non-powered, exempt2 reports
- Captura G32750DISLODGER, STONE, BASKET, URETERAL, METAL1 report
- Captura G32781DISLODGER, STONE, BASKET, URETERAL, METAL1 report
- Captura G53630Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura G56052Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura G56055Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura G56128Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura G56722Endoscopic grasping/cutting instrument, non-powered, exempt1 report
- Captura G56723Endoscopic grasping/cutting instrument, non-powered, exempt1 report
Recent Captura adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Difficult to Open or Close; Difficult to Open or Close
DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT WHEN PERFORMING A BIOPSY DURING A GASTROSCOPY WITH A NASOGASTROSCOPE, THE FORCEPS OPENS AND CLOSES BUT IT REVEALS A SMALL METAL ROD IN THE IMAGE. WHEN ATTEMPTING TO RAISE THE CLAMP IN THE OPERATOR CHANNEL, IT WAS IMPOSSIBLE TO RAISE THE CLAMP. THE ENDOSCOPE WAS CAREFULLY REMOVED SO AS NOT TO INJURE THE PATIENT WITH THE INSTRUMENT [UNABLE TO REMOVE FORCEPS FROM ENDOSCOPE - SUBJECT OF REPORT]. 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 23922294 ↗InjuryNov 3, 2025Failure to Cut; Failure to Cut
DURING AN ENDOSCOPIC BIOPSY SAMPLING IN THE ESOPHAGUS, THE PHYSICIAN CHOSE A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE USER OPENED THE PACKAGE AND ADVANCED THE DEVICE THROUGH ENDOSCOPE WORKING CHANNEL TO OPERATE WHILE FOUND OUT THE CUP TIP IS TOO BLUNT TO CAPTURE THE TISSUE AND CAUSE LARGE WOUND [AND] CAUSED SIGNIFICANT BLOOD LOSS. THE USER CHANGED TO ANOTHER BIOPSY FORCEPS TO OBTAIN THE SAMPLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. REQUESTS HAVE BEEN MADE BUT IT IS UNKNOWN HOW THE BLEEDING WAS STOPPED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 23458029 ↗InjuryMar 28, 2025Failure to Cut; Failure to Cut
DURING AN ESOPHAGEAL BIOPSY PROCEDURE, THE USER SELECTED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT USER DETECTED THE CUP STICK, AND CANNOT CUT THE TARGET TISSUE, CAUSE LARGE TRAUMA AND SERIOUS BLEEDING. AT THE TIME OF THIS REPORT, OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME HAVE BEEN UNSUCCESSFUL. ADDITIONAL ATTEMPTS TO GATHER THIS INFORMATION WILL BE MADE.
Patient problems: Gastrointestinal Hemorrhage
MAUDE report 21717755 ↗MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent
THIS SUPPLEMENTAL EMDR IS BEING SENT TO CANCEL THE INITIAL EMDR. SEE H11 FOR FURTHER JUSTIFICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21717696 ↗MalfunctionFeb 11, 2025Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close
DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT THE FORCEPS WOULD NOT OPEN OR CLOSE. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE PRELIMINARY QE EVALUATION OF THE DEVICE SHOWS THE FORCEPS CUPS WERE STUCK IN A HALF OPEN POSITION. 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 21354319 ↗MalfunctionFeb 11, 2025Difficult to Open or Close; Difficult to Open or Close
DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. THE FORCEPS WOULD NOT OPEN OR CLOSE. THE FORCEPS HEAD WAS BENT SEVERELY TO ONE SIDE. 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 21352121 ↗MalfunctionFeb 7, 2025Nonstandard Device; Difficult to Open or Close; Material Twisted/Bent; Nonstandard Device; Difficult to Open or Close; Material Twisted/Bent
DURING A GASTRIC BIOPSY, THE PHYSICIAN USED A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE. IT WAS REPORTED THAT A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GASTRIC BIOPSY PROCEDURE AND THE FORCEPS WOULD NOT OPEN OR CLOSE AFTER BEING INSERTED INTO THE ENDOSCOPE. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE PRELIMINARY QE EVALUATION OF THE DEVICE SHOWS THE FORCEPS HEAD LINK WIRE IS BROKEN. 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 21336024 ↗MalfunctionJan 22, 2025Difficult to Open or Close; Difficult to Open or Close
A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT A GASTRIC BIOPSY PROCEDURE, IN WHICH A COOK CAPTURA BIOPSY FORCEPS WITHOUT SPIKE, WAS USED. IT WAS REPORTED THAT THE FORCEPS WOULD NOT OPEN OR CLOSE AFTER BEING INSERTED INTO THE ENDOSCOPE HAD TO BE BROKEN IN ORDER TO REMOVE IT. IT WAS NOT POSSIBLE TO TAKE A BIOPSY. 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 21207696 ↗InjuryDec 2, 2024Off-Label Use; Off-Label Use
DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION OF THE ESOPHAGUS [ABNORMAL USE], THE PHYSICIAN USED A COOK CAPTURA HOT BIOPSY FORCEPS. THE LESION WAS SEPARATED BY THERMAL BIOPSY FORCEPS TO STOP BLEEDING, AND THE FRONT END OF THE BIOPSY FORCEPS WAS SUDDENLY BENT AND BROKEN, RESULTING IN THE RUPTURE OF THE BLOOD VESSEL, AND THE MUSCLE OF THE ESOPHAGEAL WALL WHERE THE BLOOD VESSEL WAS LOCATED PENETRATED WOUND. BLEEDING CONTROL [WAS REQUIRED]. USER IMMEDIATELY REPLACE WITH A NEW BIOPSY FORCEPS AND CLIP THE RUPTURED VESSEL TO STOP BLEEDING WITH A TITANIUM CLIP. NO OTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: Gastrointestinal Hemorrhage; Laceration(s) of Esophagus
MAUDE report 20822194 ↗MalfunctionSep 24, 2024Break; Difficult to Open or Close; Break; Difficult to Open or Close
DURING A BRONCHOSCOPY WITH ION ROBOT, THE PHYSICIAN USED A COOK CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE. IT WAS INITIALLY REPORTED THAT THE BRONCH FORCEPS MALFUNCTIONED AND BROKE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 27AUG2024 WHICH STATED WHEN GOING TO COLLECT TISSUE SPECIMEN IN THE LUNG THE DISTAL END OF THE FORCEPS BROKE UPON INITIALLY OPENING THE FORCEPS. ON (B)(6) 2024, THE DEVICE WAS EVALUATED AND FOUND TO BE STUCK OPEN AND UNABLE TO BE CLOSED. 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 20290569 ↗MalfunctionAug 13, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close
DURING A ROBOTIC BRONCHOSCOPY WITH TRANSBRONCHIAL BIOPSY (TBBX) AND ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) WITH AN ION ARTICULATING CATHETER, THE PHYSICIAN USED A COOK CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE IT WAS REPORTED THAT DEVICE WAS INSERTED INTO THE ION ARTICULATING CATHER AND IT WAS FORCED OPEN BY ITSELF AND STAYED OPEN, IT WOULDN¿T CLOSE. THE DOCTOR HAD TO EXTRACT THE ION ARTICULATING CATHETER WITH THE FORCEPS IN PLACE FROM THE PATIENT. TECH THEN CUT THE FORCEPS FROM THE HANDLE IN ORDER TO GET IT OUT OF THE CATHETER. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A THERAPEUTIC BRONCHOSCOPE WAS USED TO CONFIRM NO AIRWAY INJURY OCCURRED. 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 AND THE PATIENT WAS DISCHARGED TO HOME [THE] SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972794 ↗MalfunctionAug 9, 2024Difficult to Open or Close; Difficult to Open or Close
DURING AN UNKNOWN PROCEDURE, THE USER SELECTED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT IT FELT LIKE THE DRIVE WIRE OF THE COMPLAINT DEVICE BROKE AND WOULD NOT OPEN/CLOSE APPROPRIATELY. THE PROCEDURE WAS FINISHED WITH THE ANOTHER OF THE SAME DEVICE BUT DIFFERENT LOT NUMBER. 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 19951201 ↗MalfunctionAug 8, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close
DURING A BRONCHOSCOPY, THE USER SELECTED A COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT IT SOUNDED LIKE SOMETHING SNAPPED AND MECHANICAL MECHANISM WAS DAMAGED THAT THE FORCEPS WOULD NOT FUNCTION, WOULD NOT OPEN/CLOSE APPROPRIATELY. THIS OCCURRED OUTSIDE OF THE BODY AS THEY ALWAYS CHECK DEVICES BEFORE THEY USE THEM. THE PROCEDURE WAS FINISHED WITH THE ANOTHER OF THE SAME DEVICE BUT DIFFERENT LOT NUMBER. 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 19944798 ↗MalfunctionJul 16, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close
DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT THESE TWO FORCEPS BROKE DURING PROCEDURES TODAY. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RETURNED ON 21JUN2024 FOR EVALUATION. THE QUALITY ENGINEERING INITIAL ASSESSMENT STATED THAT THE DEVICE RETURNED WITH THE CUPS OPENED AND WOULD NOT CLOSE WHEN HANDLE WAS MANIPULATED. 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 19749811 ↗MalfunctionJul 16, 2024Nonstandard Device; Difficult to Open or Close; Nonstandard Device; Difficult to Open or Close
DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) COOK CAPTURA MINI BIOPSY FORCEPS W/O SPIKE. IT WAS REPORTED THAT TWO FORCEPS BROKE DURING PROCEDURES. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RETURNED ON 21JUN2024 FOR EVALUATION. THE QUALITY ENGINEERING INITIAL ASSESSMENT STATED THAT THE DEVICE RETURNED WITH THE CUPS OPENED AND WOULD NOT CLOSE WHEN HANDLE WAS MANIPULATED. 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 19749804 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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