BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10434096 · Received August 20, 2020

    Report

    Report Number
    3005975494-2020-00018
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Report Date
    September 24, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION (H6, H10) REGARDING THE REPORTED EVENT. THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED. THE PROBABLE CAUSE HAS BEEN DETERMINED AS USER MISHANDLING, IMPROPER REPROCESSING OR UNAUTHORIZED REPAIR. PER THE PRODUCT INSTRUCTIONS FOR USE (IFU)-MAINTENANCE MANUAL: "WARNING-HEALTH HAZARDS: THIS PRODUCT IS A PRECISION DEVICE; HANDLE IT WITH CARE. AVOID ROUGH OR VIOLENT HANDLING, WHICH MAY CAUSE EQUIPMENT DAMAGE. CAUTION: -WHEN DISCONNECTING PLUGS OF INSTRUMENTS OR POWER CORDS, ALWAYS HOLD THE PLUG. PULLING THE CABLE MAY RESULT IN DAMAGING OF THE WIRES. -NEVER IMMERSE THE UNIT IN WATER, CLEAN OR DISINFECT BY IMMERSION, GAS STERILIZATION OR AUTOCLAVING. IT MAY CAUSE EQUIPMENT DAMAGE. -DO NOT CLEAN THE CONNECTORS OR THE ALTERNATING CURRENT POWER INLET. CLEANING THEM CAN DEFORM OR CORRODE THE CONTACTS, WHICH COULD DAMAGE THE UNIT. -DO NOT WIPE THE EXTERNAL SURFACE WITH HARD OR ABRASIVE WIPING MATERIAL. THE SURFACE WILL BE SCRATCHED. -THE NOSE CONE AND ANY PROBES MUST BE DISASSEMBLED FROM THE TRANSDUCER AND THE CLEANING STYLET REMOVED FROM WITHIN THE TRANSDUCER PRIOR TO CLEANING AND STERILIZATION. -AFTER EACH USE OR PRIOR TO CLEANING AND STERILIZING, CAREFULLY INSPECT TRANSDUCER AND CABLE FOR TEARS, CRACKS OR OTHER SIGNS OF DAMAGE. -NEVER USE DAMAGED EQUIPMENT. CAUTIONS-REPAIR AND MAINTENANCE: IF THE GENERATOR AND / OR THE ACCESSORIES HAVE A VISIBLE DAMAGE, DO NOT USE THE SYSTEM AND CONTACT OLYMPUS. IF THE GENERATOR AND / OR THE ACCESSORIES ARE NOT WORKING PROPERLY, USE THE INFORMATION IN THIS CHAPTER (1) TO IDENTIFY AND CORRECT THE MALFUNCTION. IF THE PROBLEM CANNOT BE RESOLVED BY THE DESCRIBED REMEDIAL ACTION, STOP USING THE SYSTEM AND CONTACT OLYMPUS FOR REPAIR. REPAIRS MUST ONLY BE CARRIED OUT BY OLYMPUS OR A FIRM AUTHORIZED BY OLYMPUS." DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS FOUND TO HAVE A DAMAGED TRANSDUCER. THE CAUSE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED CANNOT PLUG THE TRANSDUCER INTO THE GENERATOR AS THE TRANSDUCER WAS BROKEN. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894590 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1