BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 14514742 · Received May 26, 2022

    Report

    Report Number
    1216677-2022-00157
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    April 21, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    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

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION . X-REVIEW DHR X-INSPECT RETURNED SAMPLES . *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 11/05/2015 UNDER WORK ORDER (B)(4) AND SOLD ON 03/21/2016. MANUFACTURING RECORD REVIEW: DHR-192951 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 REPAIR LOG 98345. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. 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 PULSE ASSEMBLY BEING CONTAMINATED. THE CONTAMINATION IS LIKELY FROM THE PROBES BEING SOAKED IN CIDEX. FAULT CODE: USER. FAILURE CODE : WEAR AND TEAR . *CORRECTION AND/OR CORRECTIVE ACTION . THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE PULSE ASSEMBLY WAS CLEANED AND ADJUSTED. THE VALVE BODY O-RINGS WERE REPLACED. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. *PREVENTATIVE ACTION ACTIVITY. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    FREEZES TOO MUCH, DEFROST DOES NOT WORK CONFIRMED COMPLAINT: PULSE ASSEMBLY CONTAMINATED. CLEANED AND ADJUSTED PULSE ASSEMBLY. REPLACED VALVE BODY O RINGS. REPAIR ORDER 98345 1216677-2022-00157 LL100 CRYOSURGICAL 900001 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    FREEZES TOO MUCH, DEFROST DOES NOT WORK. CONFIRMED COMPLAINT: PULSE ASSEMBLY CONTAMINATED. CLEANED AND ADJUSTED PULSE ASSEMBLY. REPLACED VALVE BODY O RINGS. REPAIR ORDER (B)(4) 1216677-2022-00157 LL100 CRYOSURGICAL 900001 E-COMPLAINT(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13065 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other