BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYSTIC II,MUSHROOM CUP

    MDR report key: 8692839 · Received June 12, 2019

    Report

    Report Number
    1216677-2018-00047
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    July 9, 2018
    Report Date
    June 12, 2019
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    HDB
    PMA / PMN Number
    K011532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE E-COMPLAINT # (B)(4). INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-REVIEW DHR, X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: THE AFFECTED MYSTIC VAD WAS VISUALLY AND PHYSICALLY EVALUATED WHERE IT WAS NOTED TO BE FREE OF ANY OBVIOUS DAMAGE. THE MYSTIC VAD WAS THEN FUNCTIONALLY EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED OR ABLE TO BE REPRODUCED. THE VAD WAS ACTUATED, PULLED AND MAINTAINED VACUUM IN EXCESS OF FIVE MINUTES, THE DEVICE FUNCTIONED AS INTENDED. THE "DEPRESSION" THAT WAS REPORTED WAS IDENTIFIED AS THE GATE, WHERE THE OVER-MOLD MATERIAL IS FILLED IN THE MOLD AND DID NOT HAVE ANY IMPACT ON THE DEVICE PERFORMANCE. ALL VAD DEVICES ARE INDIVIDUALLY TESTED FOR FUNCTION AND VACUUM IN ADDITION TO VISUAL INSPECTION DURING IN-PROCESS ASSEMBLY. INVENTORY REVIEW INDICATED ALL INVENTORIES HAD BEEN DEPLETED FOR LOT 230220, NO FURTHER ACTION REQUIRED AT THIS TIME. REVIEW OF THE LOT DHR DID NOT INDICATE ANY ABNORMALITY. CORRECTION AND/OR CORRECTIVE ACTION: CORRECTIVE ACTION IS NOT APPLICABLE AS THE RETURNED DEVICE FUNCTIONED AS INTENDED. THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER, OR PATIENT. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 1

    "THERE IS A DEPRESSION OF THE CUP. AND THE CUP DOES NOT HOLD. THEY HAVE TO RESET THE PRESSURE." REF E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487070 MYSTIC II,MUSHROOM CUP MYSTIC II,MUSHROOM CUP HDB COOPERSURGICAL INC. 10057 230220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other