BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD 40 ROTATABLE

    MDR report key: 2210653 · Received August 12, 2011

    Report

    Report Number
    1045254-2011-00061
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION FOR THIS REPORT WAS REPORTED TO (B)(4) FOR MEDTRONIC (B)(4) FROM A AREA DISTRIBUTER. THIS EVENT OCCURRED AT (B)(6). NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWERED DEBRIDER "BLADE TIP WAS DISLODGE FROM THE INNER SHAFT. IT WAS REMOVED FROM THE SINUS CAVITY. NO DEATH OR SERIOUS INJURY." IN AN ATTEMPT TO RETURN THE PRODUCT TO THE MANUFACTURER, THE DEVICE WAS SENT IN ERROR TO THE WRONG MANUFACTURER AND HAS NOT BEEN LOCATED BY THAT MANUFACTURER. A POWERED MICRODEBRIDER SYSTEM IS DESIGNED TO ACCOMMODATE A NUMBER OF OTORHINOLARYNGOLOGY PROCEDURES, INCLUDING FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) THAT WILL REMOVE SOFT TISSUE, HARD TISSUE, AND BONE DURING SURGICAL PROCEDURES. SINUS INDICATIONS INCLUDE SEPTOPLASTY, REMOVAL OF SEPTAL SPURS, POLYPECTOMY, ANTROSTOMY, AND ETHMOIDECTOMY/SPHENOETHMOIDECTOMY. THE SYSTEM CONSISTS OF A POWER CONTROL CONSOLE, FOOTSWITCH, CONNECTION CABLES, AND ASSORTED HANDPIECES TO DRIVE VARIOUS BURS AND BLADES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAD 40 ROTATABLE BUR, EAR, NOSE AND THROAT EQJ XOMED MFG JACKSONVILLE 1884006HR H7719918

    Patients

    Seq Age Sex Outcome Treatment
    1