Captura G47742Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002477421), received between Apr 28, 2017 and Sep 24, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionNov 23, 2021Solder Joint Fracture; Difficult to Open or Close; Solder Joint Fracture; Difficult to Open or Close

  DURING A BRONCHOSTOMY, THE PHYSICIAN USED A COOK CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE. IT WAS REPORTED THAT THE FORCEPS LODGED IN THE SCOPE. WHEN THE SCOPE WAS PULLED OUT, THE SHEATH WAS DAMAGED AND UNABLE TO BE PULLED OUT FROM THE SCOPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED ON (B)(6) 2021. THE FORCEPS WAS RETURNED WITHOUT THE CUPS. THERE WAS DAMAGE TO THE DISTAL END OF THE SHEATH. A REVIEW OF THE DRIVE WIRE IDENTIFIED THE SOLDER JOINT BETWEEN THE DRIVE WIRE AND LINK WIRES IS BROKEN. THE BROKEN SOLDER JOINT WOULD RESULT IN THE CUPS BEING UNABLE TO CLOSE. [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 12860717 ↗
• MalfunctionJul 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING A BRONCHOSCOPY, THE PHYSICIAN USED A COOK CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE. THE OPENING/CLOSURE SYSTEM BROKE DURING A FIBROSCOPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6731346 ↗
• MalfunctionApr 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK CAPTURA BRONCH BIOPSY FORCEPS NO SPIKE. THE FORCEPS WERE STICKING AND WOULD NOT OPEN. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. DURING THE DEVICE EVALUATION IT WAS FOUND THAT THE FORCEPS DID NOT CLOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6529307 ↗