BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 11361919 · Received February 22, 2021

    Report

    Report Number
    1216677-2021-00026
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 28, 2021
    Report Date
    January 12, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    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

    REVIEW DHR. INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 3/25/2019 UNDER WO #(B)(4) AND SHIPPED ON 8/15/2019. MANUFACTURING RECORD REVIEW: DHR (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT DAMAGE WAS DUE TO TRAPPED GAS IN THE EXHAUST TUBE INSIDE THE HANDLE. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME. THE FINDING INDICATES A POTENTIAL FOR ASSEMBLY ERROR, BUT THE OBSERVED NON-CONFORMITY THAT CONTRIBUTED TO THIS COMPLAINT CONDITION IS EXPECTED TO MANIFEST SOON AFTER USE NOT OVER A YEAR LATER. THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO END USER HANDLING ERROR. CORRECTIVE ACTIONS: THE UNIT WAS FITTED WITH A NEW HOSE LINE, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE TRAINING RECORDS WERE CONFIRMED TO BE CURRENT. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    "GAS WOULD SPRAY BACK ON PROVIDERS HAND. GUN EXPLODED IN HAND WHEN TURNED ON AND BUTTON PRESSED. (USER) CONTINUED TO USE DEVICE EVEN THOUGH HER HAND WAS STARTING TO FREEZE. ALTHOUGH THERE WAS PATIENT INVOLVEMENT THERE WAS NO INJURY. 1216677-2021-00026-1 900001 LL100 CRYOSURGICAL (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    REF: (B)(4). GAS WOULD SPRAY BACK ON PROVIDERS HAND. GUN EXPLODED IN HAND WHEN TURNED ON AND BUTTON PRESSED. ORDER: (B)(4). CONFIRMED COMPLAINT. LL100 CRYOSURGICAL 900001 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253848 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other