BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 15824134 · Received November 18, 2022

    Report

    Report Number
    1216677-2022-00305
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    August 19, 2022
    Report Date
    November 18, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS (B)(4) DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 03-JAN-2018 UNDER WORK ORDER (B)(4) AND SOLD ON 05-APR-2018. MANUFACTURING RECORD REVIEW: DHR-220871 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 UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 99415 THIS UNIT WAS AT CSI ON 08-NOV-2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE. THE NOZZLE EXTENSION IS BENT AND THE LUER LOCK IS BROKEN OFF. 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 NOZZLE EXTENSION BEING BENT, LUER LOCK BROKEN OFF AND THE MAIN VALVE PLUNGER BEING WORN AND CORRODED . THE NOZZLE EXTENSION BEING BENT AND THE LUER LOCK BEING BROKEN OFF IS BEING ATTRIBUTED TO THE UNIT BEING DROPPED. THE MAIN VALVE PLUNGER BEING WORN AND CORRODED IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR. *CORRECTION AND/OR CORRECTIVE ACTION THE NOZZLE EXTENSION WAS STRAIGHTENED. THE MISSING LUER LOCK AND MAIN VALVE PLUNGER WERE REPLACED.. THE UNIT WAS TESTED OK TO FORM-PROD 682 AND IS WAITING TO BE RETURNED TO THE CUSTOMER. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    THE LIQUID NITROGEN WAS CRYSTALLIZING INSIDE THE NOZZLE BLOCKING IT SO IT WOULD NOT SPRAY PROPERLY. FS LOG# (B)(4) 1216677-2022-00305 WALLACH ULTRA FREEZE 900076 (B)(4).

    Description of Event or Problem · 0

    THE LIQUID NITROGEN WAS CRYSTALLIZING INSIDE THE NOZZLE BLOCKING IT SO IT WOULD NOT SPRAY PROPERLY. FS LOG# (B)(4). WALLACH ULTRA FREEZE 900076 E-COMPLAINT(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228339 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other