BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 15386831 · Received September 8, 2022

    Report

    Report Number
    1216677-2022-00259
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 26, 2022
    Report Date
    December 8, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: X-NO SAMPLE RETURNED . X-REVIEW DHR . *ANALYSIS AND FINDINGS : (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 30-JUN-2022 UNDER WORK ORDER (B)(4) AND SOLD ON 25-JUL-2022. MANUFACTURING RECORD REVIEW: DHR-321792 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE FOR THIS ISSUE COULD BE RELIABLY DETERMINED AT THIS TIME, AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. *CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. TECH OPS PROJECT NUMBER (B)(4) HAS BEEN OPENED TO INVESTIGATE THE "STUCK TRIGGER" COMPLAINTS. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    FROM MEDWATCH 2000330000-2022-8050. NARRATIVE FROM STAFF: CRYOTHERAPY GUN FROZE IN OPEN POSITION WHILE USING TO TREAT PLANTAR WARTS. THIS WAS THE FIRST OF 2 EPISODES THAT I REPORTED FOR THIS SAME ISSUE. NARRATIVE FROM OFFICE NOTE: THE TRIGGER ON THE CRYOTHERAPY GUN FROZE IN THE OPEN POSITION. I WAS UNABLE TO STOP THE FLOW OF LIQUID NITROGEN THROUGH THE NOZZLE. I WAS ABLE TO COMPLETE THE PROCEDURE BY DIRECTING THE GUN AWAY FROM THE PATIENT BETWEEN THE INTERMITTENT PULSING PERIODS WHEN THE CRYOTHERAPY WAS BEING APPLIED. 1216677-2022-00259 WALLACH ULTRA FREEZE 900076 E-COMPLAINT-2022-08-0000521.

    Description of Event or Problem · 0

    FROM MEDWATCH (B)(4). NARRATIVE FROM STAFF: CRYOTHERAPY GUN FROZE IN OPEN POSITION WHILE USING TO TREAT PLANTAR WARTS. THIS WAS THE FIRST OF 2 EPISODES THAT I REPORTED FOR THIS SAME ISSUE. NARRATIVE FROM OFFICE NOTE: THE TRIGGER ON THE CRYOTHERAPY GUN FROZE IN THE OPEN POSITION. I WAS UNABLE TO STOP THE FLOW OF LIQUID NITROGEN THROUGH THE NOZZLE. I WAS ABLE TO COMPLETE THE PROCEDURE BY DIRECTING THE GUN AWAY FROM THE PATIENT BETWEEN THE INTERMITTENT PULSING PERIODS WHEN THE CRYOTHERAPY WAS BEING APPLIED. WALLACH ULTRA FREEZE 900076 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122443 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other