BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMS SWISS LITHOCLAST LITHOTRIPTER

    MDR report key: 1675276 · Received May 6, 2010

    Report

    Report Number
    3005099803-2010-02009
    Event Type
    Malfunction
    Date Received
    May 6, 2010
    Report Date
    April 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FFK
    PMA / PMN Number
    K963285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER THE COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. THE DEVICE AT ISSUE IN THIS COMPLAINT HAS NOT BEEN RECEIVED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    NOTE: THE INCORRECT BRAND NAME, COMMON DEVICE NAME, PRODUCT CODE, AND PMA# / 510K# WERE ORIGINALLY SUBMITTED FOR THIS DEVICE. BRAND NAME CHANGED FROM "EMS SWISS LITHOCLAST LITHOTRIPTER" TO "LITHOCATCH IMMOBILIZATION DEVICE". COMMON DEVICE NAME CHANGED FROM "LITHOTRIPTOR, ELECTRO-HYDRAULIC" TO "DISLODGER, STONE, FLEXIBLE". PRODUCT CODE CHANGED FROM "FFK" TO "FGO". BLOCK G5: PMA# / 510K# CHANGED FROM "K963285" TO "EXEMPT".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A LITHOCATCH IMMOBILIZER DEVICE WAS USED IN AN UNKNOWN PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE "DOCTOR HAD A PROBLEM RETRIEVING" THE DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A LITHOCATCH IMMOBILIZER DEVICE WAS USED IN AN UNKNOWN PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THE "DOCTOR HAD A PROBLEM RETRIEVING" THE DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION. HOWEVER, NO FURTHER EVENT DETAILS HAVE BEEN MADE AVAILABLE TO BOSTON SCIENTIFIC TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMS SWISS LITHOCLAST LITHOTRIPTER LITHOTRIPTOR, ELECTRO-HYDRAULIC FFK BOSTON SCIENTIFIC - SPENCER UNK210

    Patients

    Seq Age Sex Outcome Treatment
    1