BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15284229 · Received August 24, 2022

    Report

    Report Number
    1216677-2022-00242
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    August 2, 2022
    Report Date
    October 24, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 1993. BASED ON THIS DATE, IT WAS MANUFACTURED AND DISTRIBUTED BY WALLACH SURGICAL DEVICES. THE ORIGINAL DHR AND SHIP DATE ARE NOT AVAILABLE. 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. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4) THIS UNIT WAS AT CSI ON 08/08/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE HOSE IS DISCOLORED AND IS KINKED. 5 CRYO TIPS WERE ALSO RETURNED, ALL 5 UNITS NEED NEW INSULATORS. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE VALVES AND ORINGS LEAKING. THIS IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR ON THE UNIT. CORRECTION AND/OR CORRECTIVE ACTION: DUE TO THE UNIT BEING UNREPAIRABLE, THE CUSTOMER REQUESTED US TO SCRAP THE UNIT. THE UNIT WAS SCRAPPED. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    GAS LEAKING OUT OF TRIGGER WHEN ACTIVATED. FS LOG# 98913. LL100 CRYOSURGICAL 900001 (B)(4).

    Description of Event or Problem · 0

    GAS LEAKING OUT OF TRIGGER WHEN ACTIVATED. FS LOG# (B)(4). 1216677-2022-00242 LL100 CRYOSURGICAL 900001 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477984 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other