BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 17396069 · Received July 26, 2023

    Report

    Report Number
    1216677-2023-00107
    Event Type
    Malfunction
    Date Received
    July 26, 2023
    Date of Event
    July 12, 2023
    Report Date
    August 17, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: D9, G3, G6, H2, H3, H4, H8, H10. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 14-SEP-2014 UNDER WORK ORDER 164381 AND SOLD ON 21-OCT-2014. MANUFACTURING RECORD REVIEW: DHR-164381 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 30-OCT-2015 - 80381-FREEZE BUTTON STICKS. ADJUSTED LEVERS. TESTED OK. 12-JUL-2021 - 96630-HANDPIECE DAMAGED. BROKEN INSULATOR, INLET TUBE BENT AND DEFROST TRIGGER BROKEN. REBUILT HANDPIECE. TESTED OK. 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 100625 THIS UNIT WAS AT CSI ON 13-JUL-2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE DEFROST TRIGGER BROKEN OFF. THE POTENTIAL CAUSE MAY BE ATTRIBUTED TO MISUSE BY THE CUSTOMER, THE UNIT WAS PROBABLY DROPPED. THE DEFROST TRIGGER WAS REPLACED. THE UNIT WAS TESTED OK AND WAS RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THUMB CONTROL WAS BROKEN. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT REPORTED. 900001 LL100 2023-07-0000275.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1813307 LL100 CRYOSURGICAL GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH COOPERSURGICAL, INC. 900001 0814043 888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown