BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 13417692 · Received February 1, 2022

    Report

    Report Number
    1216677-2022-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2022
    Date of Event
    December 15, 2021
    Report Date
    March 21, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INSPECT RETURNED SAMPLES: ANALYSIS AND FINDINGS : COMPLAINT (B)(4). DISTRIBUTION HISTORY: AS PER SERVICE AND REPAIR, THE COMPLAINT UNIT IS FROM 2001. BASED ON THIS DATE, IT WAS MANUFACTURED AND DISTRIBUTED BY WALLACH SURGICAL DEVICES. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE, RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. 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 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. THE FREEZE TRIGGER IS BROKEN OFF, THE HANDLES ARE CRACKED AND THE HOSE IS KINKING. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE ISSUE MAY BE DUE TO END USER MISHANDLING AND NORMAL WEAR AND TEAR. CORRECTIVE ACTIONS: THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO TREND THE COMPLAINT CONDITION. NO FURTHER CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    PRESSURE VALVE LEAKS, TRIGGER BROKEN, TIPS MISSING. CONFIRMED COMPLAINT: FREEZE TRIGGER BROKEN OFF, HANDLES CRACKED, HOSE KINKING AT GUN AND GAUGE HOUSING. REPAIR ORDER (B)(4). HISTORY: SIMILAR REPORTED.

    Description of Event or Problem · 0

    PRESSURE VALVE LEAKS, TRIGGER BROKEN, TIPS MISSING. CONFIRMED COMPLAINT: FREEZE TRIGGER BROKEN OFF, HANDLES CRACKED, HOSE KINKING AT GUN AND GAUGE HOUSING REPAIR ORDER (B)(4). HISTORY: SIMILAR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39069 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other