BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYO FRZ NO GAS

    MDR report key: 13826093 · Received March 19, 2022

    Report

    Report Number
    1216677-2022-00087
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    December 23, 2021
    Report Date
    April 25, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPER SURGICAL , INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES: ANALYSIS AND FINDINGS: COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 2004. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE AT THE INLET EXHAUST TUBE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE IS ATTRIBUTED TO WEAR AND TEAR AS THIS DEVICE HAS BEEN IN SERVICE FOR 18 YEARS. CORRECTIVE ACTIONS: THE UNIT WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING IS REQUIRED. *WAS THE COMPLAINT CONFIRMED? YES

    Description of Event or Problem · 0

    LEAK INSIDE HANDLE. CONFIRMED COMPLAINT: LEAK IN HIGH PRESSURE LINE FITTING TO VALVE BODY. INLET EXHAUST TUBE SQUASHED AND CRIMPED AT VALVE BODY. REPLACED INLET EXHAUST TUBE ASSY AND TIGHTENED HIGH PRESSURE FITTING. REPAIR ORDER (B)(4). LL100 CRYO FRZ NO GAS 900019 E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    LEAK INSIDE HANDLE CONFIRMED COMPLAINT: LEAK IN HIGH PRESSURE LINE FITTING TO VALVE BODY. INLET EXHAUST TUBE SQUASHED AND CRIMPED AT VALVE BODY. REPLACED INLET EXHAUST TUBE ASSY AND TIGHTENED HIGH PRESSURE FITTING. REPAIR ORDER (B)(4). 1216677-2022-00087-1, LL100 CRYO FRZ NO GAS 900019, E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308764 LL100 CRYO FRZ NO GAS LL100 CRYO FRZ NO GAS GEH COOPERSURGICAL, INC. 900019 FAW2BI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other