BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527

    MDR report key: 2033052 · Received March 30, 2011

    Report

    Report Number
    3005099803-2011-00947
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KOG
    PMA / PMN Number
    K010610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED. IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING DEVICE WITH BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SPONGE FROM THE RX BIOPSY CAP DISLODGED AND BECAME LODGED WITHIN THE WORKING CHANNEL OF THE ERCP SCOPE. NO PATIENT COMPLICATIONS WERE NOTED, HOWEVER, FURTHER EVENT AND PATIENT DETAILS WERE UNAVAILABLE FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - SPENCER M00545261

    Patients

    Seq Age Sex Outcome Treatment
    1