BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10284020 · Received July 16, 2020

    Report

    Report Number
    3011050570-2020-00020
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Report Date
    January 18, 2021
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE REVIEW OF THE DEVICE HISTORY RECORDS (DHR), UNIQUE DEVICE IDENTIFIER (UDI) NUMBER AND INVESTIGATION CONCLUSION. 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. BASED ON AVAILABLE INFORMATION, A PROBABLE CAUSE OF THE FOUND FAILURE CANNOT BE DETERMINED. HOWEVER, DAMAGE TO TRANSDUCER PLUG IS OFTEN INCURRED AS A RESULT OF USER ERROR. THIS PRODUCT IS A PRECISION DEVICE; HANDLE IT WITH CARE. AVOID ROUGH OR VIOLENT HANDLING, WHICH MAY CAUSE EQUIPMENT DAMAGE AS STATED ON THE IFU (INSTRUCTION FOR USE) AND AS A PREVENTIVE MEASURE, THE USER MANUAL STATES: 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.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE ADDITIONAL INFORMATION TO CLARIFY WHICH DEVICE HAD THE BROKEN TIP. ACCORDING TO ESTIMATION, THE CUSTOMER DID NOT SEND THEIR PROBE BACK WITH THEIR TRANSDUCER. WHEN ESTIMATION CONFIRMED THAT THE TIP WAS DAMAGED, THEY WERE REFERRING TO THE TRANSDUCER PLUG, WHICH WAS DAMAGED NEAR THE O-RING. BECAUSE OF THE DAMAGE, THE TRANSDUCER WAS UNABLE TO CONNECT THE GENERATOR (SPL-S) RECEPTACLE.

    Description of Event or Problem · 0

    THE CUSTOMER ALSO REPORTED THAT THE ISSUE WAS WITH THE TRANSDUCER PLUG AND NOT THE ACTUAL PROBE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE USER¿S COMPLAINT WAS CONFIRMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THE TIP IS BROKEN AND THERE IS A DAMAGED TRANSDUCER PLUG. THE ITEM WAS FOUND TO BE UNREPAIRABLE. THE DEVICE WAS RETURNED TO THE USER FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE IS A PROBLEM WITH A PROBE THAT IS BROKEN AT THE PROXIMAL END. THE TIP IS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747940 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1