BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE LITHOTRIPSY TRANSDUCER.

    MDR report key: 10247292 · Received July 8, 2020

    Report

    Report Number
    3011050570-2020-00016
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Report Date
    July 13, 2020
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE REVIEW OF THE DEVICE HISTORY RECORDS (DHR), COMPLAINT HISTORY REPORTS. 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 REVIEW OF COMPLAINT HISTORY THERE IS NO INDICATION OF SYSTEMIC FAILURE RELATED TO THE REPORTED PHENOMENON A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DAMAGE TO THE IRRIGATION PORT INDICATES HEAVY USE. IT IS LIKELY POSSIBLE THAT THE CONNECTOR BECOMES DAMAGED OVER TIME IF THE CORD WAS REPEATEDLY PULLED FROM THE RECEPTACLE WITH SIGNIFICANT FORCE WITHOUT USING THE FINGER HOLD. STERILIZATION OR REPROCESSING AGENTS MAY HAVE ALSO CONTRIBUTED TO THE DEGRADATION OF ADHESIVE USED IN THE ASSEMBLY OF THE PLUG. PER THE DEVICE IFU, THE TRANSDUCER IS VALIDATED FOR 100 REUSES AND IS NOT VALIDATED FOR HIGH-LEVEL DISINFECTION PER IFU FOR REPROCESSING INSTRUCTIONS. IT IS UNKNOWN HOW MANY USES THIS UNIT HAS ENDURED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION DETERMINED THAT THE CONNECTOR WAS BROKEN, AND THE SUCTION PORT WAS DAMAGED. THE DEVICE WAS FOUND TO BE NOT REPAIRABLE. THE SPL-T IS A NON-REPAIRABLE MODEL. THE CUSTOMER WAS INFORMED THAT REPAIRS ON THE MODEL CANNOT BE PERFORMED AND WILL NEED TO RETURN UNREPAIRED. BASED ON DEVICE EVALUATION FINDINGS, THE ROOT CAUSE OF THE ISSUE IS UNDETERMINED HOWEVER, THE LIKELY CAUSE ATTRIBUTED TO MISHANDLING AND OR MAINTENANCE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LITHOTRIPSY CAPITAL LTP3201 CABLE WAS FOUND PULLED OUT OF THE TRANSDUCER HOUSING AND WAS DETERMINED TO BE LOOSE. ACCORDING TO THE REPORTER, THE ISSUE WAS OBSERVED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORT. NO USER HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710819 SHOCKPULSE LITHOTRIPSY TRANSDUCER. LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-T

    Patients

    Seq Age Sex Outcome Treatment
    1