BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLACH ULTRA FREEZE

    MDR report key: 10750250 · Received October 28, 2020

    Report

    Report Number
    1216677-2020-00247
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    September 21, 2020
    Report Date
    October 28, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K935010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT (B)(4) *WAS THE COMPLAINT CONFIRMED? YES DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI 2002. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE 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 TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT 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 CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT'S CAP WAS NOT FULLY THREADED INTO PLACE. ROOT CAUSE: THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS END USER ERROR. NOTE: THIS IS AN OLDER VERSION OF THE PRODUCT. *CORRECTION AND/OR CORRECTIVE ACTION THE UNIT'S CAP WAS TIGHTENED SECURELY IN PLACE, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. 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

    CUSTOMER STATED "STAFF SAYS IT IS NOT WORKING" REPAIR TECH STATED "CONFIRMED COMPLAINT: OLD VERSION ULTRAFREEZE TOP CAP LOOSE AND PARTIALLY UNTHREADED PREVENTING UNIT FROM ATTACHING PROPERLY AND SEALING TO BUILD PRESSURE." INITIAL CUSTOMER FOLLOW UP SENT ON 10/20/20 SECOND CUSTOMER FOLLOW UP SENT ON 10/21/20 CUSTOMER RESPOND STATING "EVENT OCCURRED PRIOR TO PROCEDURE AND A DIFFERENT ULTRAFREEZE WAS USED FOR THE PROCEDURE." THEREFORE NO CUSTOMER INVOLVEMENT WITH THIS EVENT. CUSTOMER'S OBSERVATION OF EVENT WAS "CAP WON'T SCREW ON TIGHT - NO SEAL - POOR SPRAY". REF (B)(4) 1216677-2020-00247 WALLACH ULTRA FREEZE 900076 (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED "STAFF SAYS IT IS NOT WORKING". REPAIR TECH STATED "CONFIRMED COMPLAINT: OLD VERSION ULTRAFREEZE TOP CAP LOOSE AND PARTIALLY UNTHREADED PREVENTING UNIT FROM ATTACHING PROPERLY AND SEALING TO BUILD PRESSURE." INITIAL CUSTOMER FOLLOW UP SENT ON 10/20/20. SECOND CUSTOMER FOLLOW UP SENT ON 10/21/20. CUSTOMER RESPOND STATING "EVENT OCCURRED PRIOR TO PROCEDURE AND A DIFFERENT ULTRAFREEZE WAS USED FOR THE PROCEDURE." THEREFORE NO CUSTOMER INVOLVEMENT WITH THIS EVENT. CUSTOMER'S OBSERVATION OF EVENT WAS "CAP WON'T SCREW ON TIGHT - NO SEAL - POOR SPRAY". (B)(4). 1216677-2020-00247 WALLACH ULTRA FREEZE 900076 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217852 WALLACH ULTRA FREEZE WALLACH ULTRA FREEZE GEH COOPERSURGICAL, INC. 900076 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O