BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 16708841 · Received April 10, 2023

    Report

    Report Number
    1216677-2023-00059
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 8, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVIEW DHR INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 14/SEP/2016 UNDER WORK ORDER (B)(4) AND SOLD ON 21/OCT/2016. MANUFACTURING RECORD REVIEW: DHR-209890 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD: 13/FEB/2023- 99898- BROKEN PLASTIC- REPLACED HANDLES AND O-RINGS. 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 (B)(4) THIS UNIT WAS AT CSI ON 21/MAR/2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    DETAILS REPORTED ON INCOMING E-COMPLAINT-(B)(4) FROM FIELD SERVICE LOG #100094: CRYOSYSTEM "STILL LEAKING." "LEAKING AT HAND PIECE"

    Description of Event or Problem · 0

    LEAKING LL100 CRYOSURGICAL 900001 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819918 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other