BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPER TURBOVAC 90

    MDR report key: 5026249 · Received August 24, 2015

    Report

    Report Number
    3006524618-2015-00502
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 30, 2015
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    BWA
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT COULD NOT BE VERIFIED NOR COULD A DEFINITIVE ROOT CAUSE BE DETERMINED WITH CONFIDENCE AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THERE WAS NO INFORMATION AVAILABLE TO INDICATE WHAT THE TOTAL ACTIVATION TIME WAS, SET POINTS USED OR WHETHER A CANNULA OR ANY OTHER APPARATUS¿ WERE USED DURING THE PROCEDURE. FACTORS NOT ASSOCIATED WITH THE MANUFACTURE OR DESIGN OF THE DEVICE WHICH COULD RESULT IN DAMAGE TO THE TIP COULD BE THAT THE DEVICE CAME INTO ABRUPT CONTACT WITH A HARD (METALLIC) OBJECT, IMPROPER REMOVAL FROM AN APPARATUS, AND USE AT A HIGHER THAN RECOMMENDED SET POINT OR EXCESSIVE FORCE APPLIED TO TIP CAN ALSO LEAD TO UNINTENDED. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE USING A SUPER TURBOVAC 90 ICW WAND, THE OUTER RING DETACHED FROM THE WAND TIP WHILE INSIDE THE SURGICAL SITE. THE DETACHED PIECE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY, HOWEVER, THE EVENT CAUSED A 30 MINUTE SURGICAL DELAY. THERE HAVE BEEN NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559331 SUPER TURBOVAC 90 SHOULDER PROBES - AR BWA ARTHROCARE CORP. 1093354

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR