Captura Pro G50696Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002506961), received between Oct 16, 2018 and Dec 13, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 28, 2021Failure to Cut; Non Reproducible Results; Failure to Cut; Non Reproducible Results

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS REPORTED THAT THE DEVICE WORKED FINE GOING DOWN [THE SCOPE]. THE PHYSICIAN INDICATED IT FELT LIKE THE FORCEPS TOOK A BIGGER BITE THAN NORMAL AND IT RIPPED THE TISSUE. THEY HAD TO CLOSE THE DEFECT WITH THREE HEMOSTASIS CLIPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THREE HEMOSTASIS CLIPS WERE USED TO CLOSE THE BIOPSY SITE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 13092840 ↗
• MalfunctionSep 4, 2020Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE JAWS [CUPS] WERE NOT LINING UP PROPERLY. THIS WAS NOTED AS THE FORCEPS WERE REMOVED FROM THEIR PACKAGE AND TESTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10493381 ↗
• MalfunctionSep 4, 2020Failure to Align; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE JAWS [CUPS] WERE NOT LINING UP PROPERLY. THIS WAS NOTED AS THE FORCEPS WERE REMOVED FROM THEIR PACKAGE AND TESTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10493380 ↗
• MalfunctionSep 4, 2020Failure to Align; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE JAWS [CUPS] WERE NOT LINING UP PROPERLY. THIS WAS NOTED AS THE FORCEPS WERE REMOVED FROM THEIR PACKAGE AND TESTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10493379 ↗
• MalfunctionSep 4, 2020Failure to Align; Failure to Align

  IN PREPARATION FOR AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE JAWS [CUPS] WERE NOT LINING UP PROPERLY. THIS WAS NOTED AS THE FORCEPS WERE REMOVED FROM THEIR PACKAGE AND TESTED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10493332 ↗
• InjuryOct 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A COLONOSCOPY, THE PHYSICIAN USED A COOKC APTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE USER HAD A HARD TIME OPENING AND CLOSING THE DEVICE, AND THE CUPS EVENTUALLY BROKE OFF. THE ENDOSCOPE WAS REMOVED TO REMOVE THE FORCEPS FROM THE ENDOSCOPE. THE CUPS WERE REMOVED FROM THE PATIENT THROUGH THE ENDOSCOPE WITH AN UNKNOWN DEVICE. THE USER FACILITY MADE A COMMENT THAT THE DIFFICULTY MAY BE CAUSED BY THE COLON GETTING MORE "TWISTED UP" IN PEDIATRIC PATIENTS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE DETACHED PORTION OF THE FORCEPS WAS RETRIEVED ENDOSCOPICALLY WITH AN UNKNOWN DEVICE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9147712 ↗
• MalfunctionOct 16, 2018Failure to Align; Failure to Align

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. THE PHYSICIAN CLAMPED DOWN ON THE MUCOSA WITH THE CUPS OF BIOPSY FORCEPS, BUT WHEN THEY PULLED ON THE MUCOSA, THE FORCEPS CUPS WOULD NOT CUT THE MUCOSA TO GET A SAMPLE. THE DEVICE WAS REMOVED AND THEY USED ANOTHER OF THE SAME DEVICE. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS EVALUATED ON (B)(6) 2018 AND THE CUPS WERE FOUND 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 7971233 ↗