BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM

    MDR report key: 10589323 · Received September 25, 2020

    Report

    Report Number
    3011050570-2020-00087
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Report Date
    January 22, 2021
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    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. A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. THE DEVICE IFU (INSTRUCTION FOR USE) ADVISES "OLYMPUS RECOMMENDS THAT THE GENERATOR AND TRANSDUCER ARE RETURNED EVERY 24 MONTHS FOR A CALIBRATION AND SAFETY INSPECTION. TO RETURN A UNIT FOR CALIBRATION AND SAFETY INSPECTION, CONTACT OLYMPUS CUSTOMER SERVICE AND REQUEST A RETURN MATERIAL AUTHORIZATION (RMA) NUMBER. (PREVENTIVE MAINTENANCE SECTION). OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CUSTOMER RESPONSE AND UPDATES.

    Description of Event or Problem · 0

    THE REPORTED EVENT OCCURRED AT THE BEGINNING OF A THERAPEUTIC PROCEDURE. NO OTHER DEVICES WERE INVOLVED IN THIS EVENT. THERE WAS A DELAY OF APPROXIMATELY 15-30 MINUTES. THE PATIENT HAS AN APPOINTMENT ON (B)(6) 2020 FOR CYSTO STENT REMOVAL (NORMAL). THEY WILL ASSESS HER AT THAT TIME TO SEE IF SHE NEEDS EXTRACORPEAL SHOCKWAVE LITHOTRIPSY FOR STONE BURDEN. NO PATIENT HARM OR INJURY REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED AND EVALUATED. EVALUATION OF THE DEVICE DETERMINED THAT THE UNIT FAILED TO GENERATE OUTPUT THROUGH THE HANDPIECE WITH ERROR AND LED LIGHTED UP DUE TO A FAULTY CONNECTOR SOCKET. ADDITIONALLY, 4 RUBBER FEET WERE FOUND MISSING AT THE BOTTOM OF THE UNIT. THE IDENTIFIED PARTS WERE REPLACED, DEVICE WAS REPAIRED. ONCE COMPLETED, THE DEVICE WAS TESTED AND PASSED ALL REQUIRED TESTING AND SPECIFICATIONS. EVALUATION FINDINGS CONFIRMED THE REPORTED COMPLAINT. THE ROOT CAUSE OF THE FAILURE IS UNKNOWN. LIKELY PROBABLE CAUSE COULD BE DUE TO HANDLING ISSUE AND OR MAINTENANCE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE SHOWED AN ERROR LIGHT. THERE WERE NO FURTHER DETAILS PROVIDED REGARDING THE EVENT. NO PATIENT IMPACT OR HARM REPORTED DUE TO THE EVENT. NO USER HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055003 SHOCKPULSE-SE LITHOTRIPSY SYSTEM LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI INC SPL-S

    Patients

    Seq Age Sex Outcome Treatment
    1