BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM

    MDR report key: 10367436 · Received August 5, 2020

    Report

    Report Number
    3011050570-2020-00027
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Report Date
    September 2, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL INFORMATION WAS OBTAINED BY THE SERVICE SUPERVISOR AT THE USER FACILITY. THE EVENT OCCURRED BEFORE A THERAPEUTIC PERCUTANEOUS NEPHROSTOLITHOTOMY/ PCNL THERAPEUTIC PROCEDURE. THE CONNECTION BETWEEN THE CORD AND EQUIPMENT WAS CHECKED AND FOUND TO BE SECURED WITH NO CABLE DAMAGE DURING THE INSPECTION PRIOR TO USE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THE REPORTED EVENT. THERE WAS A DELAY IN THE PROCEDURE WHICH WAS RESCHEDULED AND COMPLETED FOUR DAYS AFTER THE ISSUE OCCURRED. THE SERIAL NUMBER FOR THE REPLACEMENT DEVICE WAS (B)(6). DEVICE HISTORY RECORD REVIEW WAS NOT AVAILABLE FOR REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING THE EVALUATION THE REPORTED ISSUE WAS CONFIRMED. DURING THE INSPECTION THE UNIT FAILED TO POWER THE HAND PIECE WHEN EITHER S OR H BUTTONS WERE PRESSED. THIS WAS DUE TO A LOOSE BLACK WIRE FROM THE CONNECTOR ON THE POWER SUPPLY BOARD. NO OTHER ISSUES OR INJURIES HAVE BEEN REPORTED. IF ANY ADDITIONAL INFORMATION IS OBTAINED A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THER USER FACILITY REPORTED THAT THE GENERATOR WAS NOT FUNCTIONING AS INTENDED, THE UNIT WAS NOT POWERING THE HANDPIECES. THE ISSUE OCCURRED DURING PREPARATION OF A PROCEDURE. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831451 SHOCKPULSE-SE LITHOTRIPSY SYSTEM LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-S

    Patients

    Seq Age Sex Outcome Treatment
    1