BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD® BLADE

    MDR report key: 3973441 · Received August 1, 2014

    Report

    Report Number
    1045254-2014-00162
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP FROM THE CUSTOMER WAS RECEIVED INDICATING THAT THE PATIENT HAD PLAIN X-RAYS OF THE SINUSES SHOWING NO METALLIC FOREIGN BODY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE THREE BLADES WERE RETURNED FOR ANALYSIS. THE PRODUCT ANALYSIS INDICATES THAT SAMPLE A TIP WAS NOT ATTACHED AND NOT RETURNED; SAMPLE B WOULD INDEX BUT IT WOULD NOT MOVE THE TIP; SAMPLE C WOULD INDEX; HOWEVER, IT WAS BINDING. THERE WAS NO EVIDENCE OF IMPROPER LOADING, EXCESS PRESSURE APPLIED WHILE IN USE, AND NO PHYSICAL DAMAGE TO INDICATE MISUSE/MISHANDLING. THEREFORE, MISUSE AND MISHANDLING HAVE BEEN RULED OUT AS A POTENTIAL CAUSE. THE INFORMATION PROVIDED INDICATES INTERFERENCE OCCURRED BETWEEN THE INNER/MIDDLE ASSEMBLY AND THE OUTER SHEATH AT THE APEX OF THE BEND, WHICH MAY HAVE TAKEN PLACE DURING MANUFACTURING/PRODUCTION. RESULT: STRESS PROBLEM. CONCLUSION: MANUFACTURING DEFICIENCY. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Description of Event or Problem · 1

    A SALES REP REPORTED THAT THREE BLADES FAILED DURING A CASE WHILE HE WAS PRESENT. THE SALES REP STATED THAT ALL THREE BLADES WORKED CORRECTLY AT FIRST, THEN STOPPED ROTATING. ON THE FIRST BLADE, THE BLADE MECHANISM ALONG WITH THE SPRINGS AND THE COILS RETRACTED DISTALLY (POPPED FORWARD OUT OF THE CANNULA) BUT DID NOT DETACH FROM THE BLADE; IT WAS STILL CONNECTED. ON ALL THREE BLADES THE FUNCTION THAT ALLOWS THE BLADE TO ROTATE WOULD STOP. THEY DID NOT HAVE ANY MORE OF THAT PRODUCT AFTER THE THREE BLADES FAILED. THE SURGEON HAD TO USE A 40 DEGREE ANGLE BLADE TO GET INSIDE THE SINUS (TYPICALLY REQUIRES A 60 DEGREE ANGLE BLADE). ANALYSIS INDICATED THAT THE TIP OF ONE OF THE BLADES WAS DETACHED/MISSING. THERE WAS NO REPORTED PATIENT IMPACT AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. FOLLOW-UP WITH THE SALES REP, WHO SPOKE WITH THE PHYSICIAN, INDICATED THAT THE PHYSICIAN IS CONFIDENT THAT THE BLADE TIP WAS NOT LEFT IN THE PATIENT DURING THE SURGERY, AND IS NOT RECOMMENDING AN MRI OR X-RAY TO CONFIRM. THE PHYSICIAN REPORTED THAT THE PATIENT IS RECOVERING AS EXPECTED AND HAS NOT EXPERIENCED ANY COMPLICATIONS.

    Description of Event or Problem · 1

    FOLLOW-UP FROM THE CUSTOMER INDICATES THAT THE PATIENT HAD PLAIN X-RAYS OF THE SINUSES SHOWING NO METALLIC FOREIGN BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451168 RAD® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884016HRE 0207831388

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR