BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 12781224 · Received November 9, 2021

    Report

    Report Number
    1216677-2021-00256
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 6, 2021
    Report Date
    January 23, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLE RETURNED. DISTRIBUTION HISTORY: A DISTRIBUTION HISTORY IS NOT POSSIBLE WITH THE INFORMATION AVAILABLE. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE IDENTIFIED AT THE TIME OF THIS INVESTIGATION AS NO SERIAL NUMBER WAS PROVIDED. HOWEVER, IT SHOULD BE NOTED MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO INFORMATION AVAILABLE. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS NOT RETURNED. VISUAL EVALUATION: THE COMPLAINT UNIT WAS NOT RETURNED. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY WAS NOT POSSIBLE AS NO UNIT WAS RETURNED. ROOT CAUSE: A ROOT CAUSE IS NOT APPLICABLE AS THE UNIT WAS NOT RETURNED FOR EVALUATION. CORRECTIVE ACTIONS NO CORRECTIVE ACTIONS APPLICABLE AS NO EVALUATION WAS POSSIBLE. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? NO.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Description of Event or Problem · 0

    CUSTOMER STATED: "WE HAVE A NITRATE OXIDE CYLINDER WITH WALLACH LL-100 ATTACHMENT AND HAVE BEEN EXPERIENCING SOME ISSUES WITH THIS FOR EXAMPLE WE HAD A CRYO CAUTTERY PROCEDURE, AND IT DID NOT DE-FREEZE FULLY THEREFORE WAS STILL ATTACHED TO THE PATIENT WHICH THEN MADE THIS AN UNCOMFORTABLE EXPERIENCE". 1216677-2021-00256-1 900001 LL100 CRYOSURGICAL (B)(4).

    Description of Event or Problem · 0

    REPORT STATED- WE HAVE A NITRATE OXIDE CYLINDER WITH WALLACH LL-100 ATTACHMENT AND HAVE BEEN EXPERIENCING SOME ISSUES WITH THIS FOR EXAMPLE WE HAD A CRYO CAUTTERY PROCEDURE, AND IT DID NOT DE-FREEZE FULLY THEREFORE WAS STILL ATTACHED TO THE PATIENT WHICH THEN MADE THIS AN UNCOMFORTABLE EXPERIENCE. WE HAVE HAD THIS ATTACHMENT FOR A NUMBER OF YEARS NOW. 10/21/2021- UPDATE- UNIT WOULD NOT DEFROST AND TIP BECAME STUCK TO THE PATIENTS CERVIX. PROCEDURE-CRYO THERAPY TO CERVIX. ANY IMPACT ON PATIENT- PER RESPONSE- NIL NOTED ON REMOVAL. LL100 CRYOSURGICAL 900001, E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674688 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other