BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL-CO2 CRYOSURGICAL SYS

    MDR report key: 15086236 · Received July 22, 2022

    Report

    Report Number
    1216677-2022-00214
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 20, 2022
    Report Date
    September 7, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 03/28/2016 UNDER WORK ORDER (B)(4). AND SOLD ON 06/21/2016. MANUFACTURING RECORD REVIEW: DHR-200992 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: 89690-GAS LEAKING-DAMAGED TUBE/HOLE IN GAS LINE-UNIT WAS REPAIRED-08/02/2018. 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. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE GAUGE COVER WAS CRACKED AND THE HANDLES ARE BROKEN. 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 ORINGS LEAKING. THIS IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR ON THE UNIT. CORRECTIVE ACTIONS. THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE ORINGS, GAUGE COVER AND HANDLES WERE REPLACED. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO FURTHER TRAINING REQUIRED AT THIS TIME. *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    LOG 98747. NOZZLE SPITTING OUT CO2. LL-CO2 CRYOSURGICAL SYS 900161. E-COMPLAINT (B)(4).

    Description of Event or Problem · 0

    LOG 98747. NOZZLE SPITTING OUT CO2. 1216677-2022-00214-1 LL-CO2 CRYOSURGICAL SYS 900161 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102927 LL-CO2 CRYOSURGICAL SYS LL-CO2 CRYOSURGICAL SYS GEH COOPERSURGICAL, INC. 900161 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R