BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 12352521 · Received August 23, 2021

    Report

    Report Number
    1216677-2021-00177
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 17, 2021
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 2021-08-0000148. WAS THE COMPLAINT CONFIRMED? YES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 03/23/2017 UNDER WO # (B)(4) AND SHIPPED ON 08/09/2017. MANUFACTURING RECORD REVIEW: DHR 202709 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. 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 CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE TO THE TRIGGER. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: AN IMPACT TO THE UNIT, FROM A DROP, WOULD BE CONSISTENT WITH A BROKEN TRIGGER. ALTHOUGH A BROKEN TRIGGER WAS NOTED, THE ROOT CAUSE IS NOT DEFINITIVELY DETERMINED. CORRECTION AND/OR CORRECTIVE ACTION : THE UNIT'S TRIGGER WAS REPAIRED, TESTED AND RETURNED TO THE CUSTOMER. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED. PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    LEVER BROKEN. ORDER: (B)(4). CONFIRMED COMPLAINT:TRIGGER BROKEN OFF. 1216677-2021-00177 WALLACH ULTRA FREEZE 900076 E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    LEVER BROKEN. ORDER: (B)(4). CONFIRMED COMPLAINT:TRIGGER BROKEN OFF. WALLACH ULTRA FREEZE 900076. E-COMPLAINT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254230 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O