BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 17458022 · Received August 4, 2023

    Report

    Report Number
    1216677-2023-00112
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    June 29, 2023
    Report Date
    August 17, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 17/MAY/2018 UNDER WORK ORDER (B)(4) AND SOLD ON (B)(6) 2018. MANUFACTURING RECORD REVIEW: DHR-243356 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: (B)(6) 2021 - 95675-LEAKING-THE INSULATOR TUBE IS LOOSE. TIGHTENED INSULATOR TUBE AND 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 100631 THIS UNIT WAS AT CSI ON (B)(6) 2023. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE VALVE BODY O-RINGS LEAKING. THE PULSE PISTON WAS CONTAMINATED WITH COLD SOAK SOLUTION. THE LEAKING O-RINGS IS ATTRIBUTED TO NORMAL WEAR AND TEAR. THE CONTAMINATION OF THE PULSE PISTON IS ATTRIBUTED TO COLD SOAK SOLUTION LEFT INSIDE THE TIPS IS GETTING INTO THE GUN AFTER THE TIPS ARE SOAKED. THE PULSE HOUSING ASSEMBLY WAS CLEANED. THE VALVE BODY O-RINGS, PULSE PISTON AND SPRING WERE ALL REPLACED. THE UNIT WAS TESTED OK AND WAS RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO COOPER SURGICAL FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUN WAS NOT WORKING PROPERLY. NO ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. 1216677-2023-00112 900001; LL100 023-07-0000290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899617 LL100 CRYOSURGICAL GENERAL CRYOSURGICAL SYSTEM, CRYOGEN GAS, MECHANICAL GEH COOPERSURGICAL, INC. 900001 N/A 888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown