BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 12824991 · Received November 16, 2021

    Report

    Report Number
    1216677-2021-00266
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    August 18, 2021
    Report Date
    March 10, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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: COMPLAINT: (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 07/31/2018 UNDER WO#: (B)(4) AND SHIPPED ON 11/28/2018. MANUFACTURING RECORD REVIEW: DHR-232774 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED IN 2019 AND 2020. THE REASON FOR REPAIRS WERE DIFFERENT FROM THE CURRENT ISSUE. 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. HOWEVER, BASED ON LOG: 96925 THIS UNIT WAS AT CSI ON 09/01/2021. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE PROBABLE ROOT CAUSE WAS CUSTOMER MISUSE OR DROPPING OF THE UNIT. WAS THE COMPLAINT CONFIRMED? YES. CORRECTION AND/OR CORRECTIVE ACTION. THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. 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

    METAL SPRAY TIP BROKE OFF. CONFIRMED COMPLAINT: LUER LOCK BROKEN OFF. PER (B)(6): BROKEN TIP DOES NOT HAVE NEGATIVE EFFECT ON PATIENT/USER AS THE DEVICE WOULD NOT FREEZE SUFFICIENTLY. REPAIR ORDER LOG#: (B)(4). 1216677-2021-00266 WALLACH ULTRA FREEZE 900076 E-COMPLAINT: (B)(4).

    Description of Event or Problem · 0

    METAL SPRAY TIP BROKE OFF. CONFIRMED COMPLAINT: LUER LOCK BROKEN OFF. PER RAY: BROKEN TIP DOES NOT HAVE NEGATIVE EFFECT ON PATIENT/USER AS THE DEVICE WOULD NOT FREEZE SUFFICIENTLY. REPAIR ORDER LOG #: 96925. WALLACH ULTRA FREEZE 900076. E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723357 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other