BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX

    MDR report key: 10417192 · Received August 17, 2020

    Report

    Report Number
    3011050570-2020-00044
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 22, 2020
    Report Date
    October 16, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED. THERE WAS A BREAKAGE ON THE PROBE TUBING NEAR THE PROXIMAL END WHERE THE BRAZE JOINT IS LOCATED. A REVIEW OF DHR RECORDS PROVIDES NO INDICATION THAT MANUFACTURING PROCESSES CONTRIBUTED TO THE FAILURE. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. FRACTURE OF THE PROBE IS OFTEN A RESULT OF USER MISHANDLING DURING USE. THE PROBE MUST BE KEPT CONCENTRIC TO THE ENDOSCOPE'S INSTRUMENT CHANNEL WHILE ACTIVE TO PREVENT THE INTRODUCTION OF UNNECESSARY TORQUE ON THE PROBE. IF ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE SALES REPRESENTATIVE CONFIRMED THAT THE DEVICE WILL BE RETURNED TO OLYMPUS FOR EVALUATION. IF ADDITIONAL INFORMATION IS OBTAINED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AN OLYMPUS REPRESENTATIVE REPORTED THAT A PROBE BROKE CLOSE TO THE TRANSDUCER. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877398 SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-PDBX376 KR908659

    Patients

    Seq Age Sex Outcome Treatment
    1