BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N20 SPHERICAL PROBE

    MDR report key: 10401885 · Received August 13, 2020

    Report

    Report Number
    1216677-2020-00176
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 24, 2020
    Report Date
    January 26, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HQA
    UDI-DI
    00888937004168
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. REVIEW DHR: INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED IN 1997. 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 NO SIMILAR REPORTED COMPLAINT CONDITION. THE COMPLAINT DOES NOT SPECIFY A COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. THE SILICONE TUBING WAS TORN. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. SERVICE & REPAIR CONFIRMED THE COMPLAINT UNIT HAD HIGH FREEZE FLOW. ROOT CAUSE: HIGH FREEZE FLOWS WILL AFFECT THE UNIT FROM REACHING OPTIMAL TEMPERATURE. THIS UNIT'S SPRING HOUSE ASSEMBLY REQUIRED RE-WORKING INDICATING THE BALL SETTING WAS OFF AFTER 23 YEARS. THE BALL IS SOLDERED ONTO THE END OF A WIRE (SPRING ASSEMBLY) WHERE BOTH ARE EXPOSED TO THE RUSHING GAS AND MOVED INTO THE PROPER SEATING POSITION IN THE EXITING ORIFICE. OVER TIME, THE SEATING WAS OFF. AS THIS DEVICE HAS NO RECORD OF BEING SERVICED IN THE 23 YEARS OF USE, THIS COMPLAINT CONDITION IS BEING ATTRIBUTED TO WEAR & TEAR. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATION 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. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    REPAIR TECHNICIAN STATED: "FOUND SILICON TORN. HIGH FREEZE FLOW.15MM SHOULD BE 10MM". 1216677-2020-00176-1 N20 SPHERICAL PROBE 139. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION IS BEING INVESTIGATED BY COOPERSURGICAL, INC.

    Description of Event or Problem · 1

    ORDER: 94632. FOUND;SILICON TORN. HIGH FREEZE FLOW.15MM SHOULD BE 10MM. REF E-COMPLAINT-(B)(4). N20 SPHERICAL PROBE 139 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869620 N20 SPHERICAL PROBE N20 SPHERICAL PROBE HQA COOPERSURGICAL, INC. 139 N/A 00888937004168

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other