BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER MULTIVAC 50 IFS

    MDR report key: 9808150 · Received March 9, 2020

    Report

    Report Number
    3006524618-2020-00095
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 13, 2020
    Report Date
    April 13, 2020
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470006551
    PMA / PMN Number
    K180848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A PICTURE OF THE DEVICE WAS PROVIDED, HOWEVER IS ONLY OBSERVED A PIECE OF APPARENTLY METAL PART AND THE PICTURE DOES NOT SHOW THE TIP OF THE WAND. A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER 2032706 SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW FOR LOT NUMBER 2032706 FOR THE PAST 3 YEARS FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. WITHOUT THE REPORTED PRODUCT A VISUAL INSPECTION AND FUNCTIONAL EVALUATION CANNOT BE PERFORMED AND CUSTOMER´S COMPLAINT CANNOT BE CONFIRMED. POTENTIAL FACTORS UNRELATED TO THE DESIGN OR MANUFACTURE OF THE DEVICE THAT MAY LEAD TO ¨BROKEN TIP¨ INCLUDE, BUT ARE NOT LIMITED TO: THE DEVICE COMING INTO ABRUPT CONTACT WITH A HARD (METALLIC) OBJECT, IMPROPER INSERTION OR REMOVAL FROM AN APPARATUS, USE AT A HIGHER THAN RECOMMENDED SET POINT OR EXCESSIVE FORCE APPLIED TO THE TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC KNEE SURGERY, WHILE RESECTING TISSUE WITH THE AMBIENT SUPER MULTIVAC 50 IFS WAND, PART OF THE ELECTRODE PLATE AT THE TIP OF THE WAND BROKE OFF. THIS CAUSED THE ALARM ON THE QUANTUM 2 UNIT TO GO OFF, AND AN ERROR MESSAGE WAS DISPLAYED ¿E3, WAND FAULT.¿ THE WAND WOULD NO LONGER WORK THEREAFTER AND WAS REPLACED WITH ANOTHER TO COMPLETE THE PROCEDURE. THE METAL PIECE WHICH HAD BROKEN OFF WAS RETRIEVED FROM THE PATIENT¿S KNEE. THE SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269862 AMBIENT SUPER MULTIVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. ASHA4830-01 2032706 00817470006551

    Patients

    Seq Age Sex Outcome Treatment
    1