BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1932143 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05106
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) - INTERVENTION REQUIRED TO CORRECT THE BOWEL PERFORATION. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF FOUR DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT #'S 3005099803-2010-05110, 3005099803-2010-05111 AND 3005099803-2010-05112 ADDRESS THESE FOUR DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOUR RADIAL JAW 4 SINGLE USE BIOPSY FORCEPS STANDARD CAPACITY WERE USED DURING A COLON BIOPSY PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, ONE FORCEPS DEVICE BECAME STUCK IN THE TISSUE. NO DAMAGE WAS NOTED TO THIS DEVICE, AND IT WAS REMOVED FROM THE PATIENT BUT THE DETAILS ARE UNKNOWN. ADDITIONAL INFORMATION OBTAINED (AT A LATER DATE) INDICATED THAT A TOTAL OF FOUR FORCEPS DEVICES WERE USED DURING THIS CASE. IT WAS REPORTED THAT NO BLOOD LOSS OCCURRED, AND NO INTERVENTION WAS NEEDED DURING THE PROCEDURE. REPORTEDLY FIVE HOURS AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF BLOATING. THE PATIENT WAS SUBSEQUENTLY SENT FOR SURGERY WHERE A "MICRO-PERFORATION" (LESS THAN 5MM) WAS FOUND WITHIN THE COLON. IT COULD NOT BE OBTAINED WHAT WAS DONE TO CORRECT THE PERFORATION DURING THE SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FORCEPS, BIOPSY, NON-ELECTRIC FCL BOSTON SCIENTIFIC - COSTA RICA M00513401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R