BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB

    MDR report key: 10459596 · Received August 27, 2020

    Report

    Report Number
    3011050570-2020-00057
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    January 20, 2020
    Report Date
    August 27, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION AT SERVICE CENTER SITE IN (B)(4). EVALUATION OF DEVICE CONFIRMED THE REPORTED ISSUE. BROKEN PINS WERE FOUND ON THE DEVICE TRANSDUCER RECEPTACLE. WHEN INSPECTED WITH THE REFERENCE PART THE DEVICE MET ALL INSPECTION CRITERIA. THE DAMAGED RECEPTACLE WAS REPAIRED AND THE UNIT WAS RETURNED TO THE CUSTOMER. THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. IT WAS REPORTED THAT THE DEVICE TIP OF SHOCKPULSE LITHOTRIPSY WHEN ATTACHED IN THE MACHINE, IT DOES NOT DETECT AND KEEPS FLASHING. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE REPORTED FAILURE IS A KNOWN PHENOMENON AND IS PRODUCED AS A RESULT OF DAMAGE TO THE TRANSDUCER PLUG AND/OR RECEPTACLE. DAMAGE TO THE RECEPTACLE IS OFTEN INCURRED AS A RESULT OF USER ERROR, OFTEN THE USER DOES NOT REALIZE ALL CONNECTIONS ARE PUSH/PULL AND INSTEAD THE PLUG IS TWISTED UPON CONNECTION OR REMOVAL. THIS ACTION RESULTS IN DAMAGE TO THE PINS INTERNAL TO THE SOCKET AND MAY CRACK OR DAMAGE THE RECEPTACLE HOUSING. PER THE USER¿S MANUAL, THE TRANSDUCER RECEPTACLE IS ADDRESSED, "CONNECT THE TRANSDUCER TO THE GENERATOR BY PRESSING THE PLUG STRAIGHT IN. CAUTION DO NOT TWIST OR TURN THE PLUG ¿, CONNECT THE TRANSDUCER TO THE GENERATOR BY ALIGNING THE KEY WAY OF THE TRANSDUCER CONNECTOR WITH THE KEY WAY SLOT ON THE TRANSDUCER RECEPTACLE ON THE FRONT PANEL. PUSH STRAIGHT IN. CAUTION DO NOT TWIST OR TURN THE PLUG." OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TIP OF SHOCKPULSE LITHOTRIPSY WHEN ATTACHED IN THE MACHINE, IT DOES NOT DETECT AND KEEPS FLASHING. NO FURTHER DETAILS WERE REPORTED REGARDING THE EVENT. NO PATIENT INVOLVEMENT WAS REPORTED. NO USER HARM OR INJURY ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922939 SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-SR

    Patients

    Seq Age Sex Outcome Treatment
    1