BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 11130987 · Received January 7, 2021

    Report

    Report Number
    1216677-2020-00308
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 11, 2020
    Report Date
    January 20, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLE RETURNED: REVIEW DHR. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 5/12/2020 UNDER WO # (B)(4) AND SHIPPED ON 12/9/2020. MANUFACTURING RECORD REVIEW: DHR 280717 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 ATTACHED 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS NOT RETURNED AS OF 3/2/2021. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT WAS NOT POSSIBLE AS UNIT WAS NOT RETURNED. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS NOT FUNCTIONALLY EVALUATED AS THE UNIT WAS NOT RETURNED. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. CORRECTIVE ACTIONS: ADDITIONAL EFFORT WAS MADE TO CONTACT THE CUSTOMER ON THE RETURN STATUS. HOWEVER, NO RESPONSE WAS PROVIDED. SHOULD THE UNIT BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    "THE FREEZE VALVE IS STUCK IN OPEN POSITION." 1216677-2020-00308-1 900001 LL100 CRYOSURGICAL (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    REPORT SUBMITTTED BY CSI SERVICE & REPAIR- THE FREEZE VALVE IS STUCK IN OPEN POSITION. THIS IS THE SECOND OOBF FOR THIS CUSTOMER. FOLLOW-UP INITIATED FOR INFORMATION ON THE FIRST COMPLAINT. (B)(4). 900001 LL100 CRYOSURGICAL (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25913 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1