BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX

    MDR report key: 10312914 · Received July 23, 2020

    Report

    Report Number
    3005975494-2020-00016
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    June 26, 2020
    Report Date
    August 17, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: CUSTOMER FOUND "BOTTOM BROKE OFF DURING A CASE." THE DEVICE WAS RETURNED, THE COMPLAINT WAS CONFIRMED, THE DEVICE WAS FRACTURED NEAR THE BRAZE JOINT AT THE PROXIMAL END. FAILURE IN THIS MANNER IS OFTEN A RESULT OF THE APPLICATION OF EXCESSIVE TORQUE DURING USE WHICH CAUSES WEAR AGAINST THE ENDOSCOPE AT THE PROXIMAL END OF THE INSTRUMENT CHANNEL. THE DEVICE IFU (SPL-IFU REV AM) WARNS ON PAGE 22, "THE PROBE IS FRAGILE. IT IS CRITICAL THAT THE SURGEON DOES NOT BEND OR TORQUE THE PROBES AGAINST THE ENDOSCOPE DURING THE PROCEDURE. THERE IS NO NEED TO ROTATE THE PROBE OR TRANSDUCER; IT WILL NOT IMPROVE FRAGMENTATION OR STONE CLEARANCE." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED AND IT WAS CONFIRMED THAT THERE WERE NO ABNORMALITIES, SPECIAL ADOPTIONS, OR VARIATIONS IN THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS DURING PREPARATION FOR USE, IT WAS NOTED THAT THE BOTTOM OF THE DEVICE WAS BROKEN OFF. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777810 SHOCKPULSE PROBE SINGLE USE, 3.40MM 3/BX LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-PDBX340 D1901149

    Patients

    Seq Age Sex Outcome Treatment
    1