BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL 3055601 SKEETER OTO-TOOL

    MDR report key: 2912000 · Received January 11, 2013

    Report

    Report Number
    1045254-2013-00034
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC XOMED INC
    Product Code
    ERL
    PMA / PMN Number
    K833874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING PRE-OP A SKEETER HANDPIECE WAS GETTING HOT. IT WAS ALSO REPORTED TO HAVE CABLE DAMAGE AND CHATTER. THE EXACT EVENT DATE WAS UNKNOWN, BUT REPORTED TO HAVE BEEN THE WEEK PRIOR TO THE NOTIFY DATE OF (B)(6) 2012. PMA: K833874

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE WAS NOVEMBER 28, 1998.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE CORD WAS PULLED OUT FROM END OF HOUSING. MOTOR WAS BAD. IT WAS REPLACED, ALONG WITH SPRING COLLAR STRAIN RELIEF, PLUG, CABLE, AND OTHER PARTS. THE ITEM WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GETS HOT. THERE WERE NO REPORTS OF PATIENT IMPACT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-OP A SKEETER HANDPIECE WAS GETTING HOT. IT WAS ALSO REPORTED TO HAVE CABLE DAMAGE AND CHATTER. THE EXACT EVENT DATE WAS UNKNOWN, BUT REPORTED TO HAVE BEEN THE WEEK PRIOR TO THE NOTIFY DATE OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18408 DRILL 3055601 SKEETER OTO-TOOL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED INC 3055601 17336100

    Patients

    Seq Age Sex Outcome Treatment
    1