BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 15259291 · Received August 19, 2022

    Report

    Report Number
    1216677-2022-00237
    Event Type
    Malfunction
    Date Received
    August 19, 2022
    Date of Event
    July 28, 2022
    Report Date
    August 19, 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-REVIEW DHR . X-INSPECT RETURNED SAMPLES . ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 07/28/2021 UNDER WORK ORDER (B)(4). AND SOLD ON 06/22/2022. MANUFACTURING RECORD REVIEW: DHR-300153 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 A REPAIR. HOWEVER, BASED ON LOG (B)(4) THIS UNIT WAS AT CSI ON 08/04/2022. 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 A BRASS CHIP GETTING CAUGHT INSIDE THE VALVE. THE BRASS CHIP POSSIBLY CAME LOOSE INSIDE THE UNIT FROM ANOTHER COMPONENT MADE FROM BRASS. FAULT CODE: COMPONENT FAILURE CODE: COULD NOT RELIABLY BE DETERMINED *CORRECTION AND/OR CORRECTIVE ACTION THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE VALVE AND ORINGS 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

    THE VALVE IS NOT WORKING. (BRIAN IN S/R DIAGNOSED IT). FS LOG# 98887. LL100 CRYOSURGICAL 900001 (B)(4).

    Description of Event or Problem · 0

    THE VALVE IS NOT WORKING. (BRIAN IN S/R DIAGNOSED IT). FS LOG# (B)(4). LL100 CRYOSURGICAL 900001 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2906330 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other