BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LM-900 N2O CE CRYOSURG SY

    MDR report key: 12268804 · Received August 3, 2021

    Report

    Report Number
    1216677-2021-00155
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    June 14, 2021
    Report Date
    January 30, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937009965
    PMA / PMN Number
    K854767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW DHR, INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 1/23/2019 UNDER WO #(B)(4) AND SHIPPED ON 7/30/2020. MANUFACTURING RECORD REVIEW: DHR 241713 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO OUTER PHYSICAL DAMAGE. UPON OPENING THE UNIT THE TUBING WAS FOUND DAMAGED FROM RUPTURING. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ASSEMBLY OF THE LINES INSIDE THE HOUSING REQUIRES THE NYLON TUBING TO BE TURNED AND CURVED TO MATE WITH THE FITTINGS. THE LINE MAY HAVE BEGUN TO KINK AND EVENTUALLY PREVENTED NORMAL GAS FLOW OR BLOCKAGE CREATING A HIGH PRESSURE POINT. HOWEVER, A ROOT CAUSE IS NOT DEFINITIVELY DETERMINED. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER UNDER WARRANTY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER TRAINING REQUIRED. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: "GAS LEAK IN METER". LM-900 N20 CE CRYOSURG SY (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "GAS LEAK IN METER". REPAIR TECH STATED "FOUND - HP LINE FORM ON/OFF TO PRESSURE GAUGE BLOWN OUT - REPLACED HP LINE". (B)(4). GAS EXPOSURE DUE TO OVER PRESSURE OF SUPPLY TANK RELATES TO A RISK OF 6 PRE AND 11 POST INDICATING A REPORTABLE EVENT PER TECH-035. 1216677-2021-00155 LM-900 N2O CE CRYOSURG SY 50501 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169265 LM-900 N2O CE CRYOSURG SY LM-900 N2O CE CRYOSURG SY GEH COOPERSURGICAL, INC. 50501 N/A 00888937009965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other