BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 1884016HR RAD60 4MM

    MDR report key: 2504521 · Received March 26, 2012

    Report

    Report Number
    1045254-2012-00092
    Event Type
    Malfunction
    Date Received
    March 26, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 2, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE DEVICE WAS NOT RETURNED. NEITHER APPLICABLE IMAGING FILMS NOR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE INFORMATION REASONABLY SUGGESTS THAT A DEVICE IN QUESTION HAS MALFUNCTIONED AS DEFINED BY THE FDA AND A REVIEW OF THE COMPLAINT HISTORY INDICATES THAT THIS PRODUCT ISSUE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST AND THEREFORE IS LIKELY TO CAUSE OR CONTRIBUTE SERIOUS INJURY IF THIS EVENT WERE TO RECUR. THIS EVENT IS BEING FILED AS ADVERSE EVENT /PRODUCT PROBLEM. DEVICE DESCRIPTION: THE INTEGRATED POWER CONSOLE (IPC) SYSTEM IS A POWERED MICRODEBRIDER, DRILL AND SAW SYSTEM THAT WILL REMOVE SOFT TISSUE, HARD TISSUE, AND BONE DURING SURGICAL PROCEDURES. THE SYSTEM CONSISTS OF A TOUCHSCREEN/USER INTERFACE, POWER CONTROL CONSOLE, FOOTSWITCH, CONNECTION CABLES, AND ASSORTED HANDPIECES TO DRIVE VARIOUS BURS, BLADES, DRILLS, RASPS, CANNULAE, AND SAWS. IT INCLUDES INTEGRATED IRRIGATION PUMPS FOR IRRIGATION OF BLADES, BURS AND FOR MOTOR COOLANT. IN ADDITION TO THE HANDPIECES AND PUMPS THERE IS A CONNECTION FOR CONTINUOUS STIMULATION OF THE VISAO STRAIGHT BURS THAT ENABLES NERVE INTEGRITY MONITORING DURING SURGICAL PROCEDURES. THE SYSTEM CAN BE USED TO CLEAR THE END OF A RIGID ROD ENDOSCOPE IN ORDER TO MAINTAIN GOOD VISUALIZATION OF ENDOSCOPIC PROCEDURES WITHOUT HAVING TO REMOVE THE SCOPE FROM THE SURGICAL SITE. THE IPC IS INDICATED FOR THE INCISION / CUTTING, REMOVAL, DRILLING, AND SAWING OF SOFT AND HARD TISSUE AND BONE, IN HEAD <(>&<)> NECK / ENT, ORAL / MAXILLOFACIAL, AND PLASTIC / RECONSTRUCTIVE / AESTHETIC, SURGICAL PROCEDURES.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED (B)(4), 2012, DURING THE INVESTIGATION OF THIS PRODUCT EVENT THAT THERE WAS ANOTHER MEDWATCH PREPARED REFERENCING THE SAME FACILITY, THE SAME SURGEON, SAME SALES REP AND SAME LOT NUMBER. THE BLADES RETURNED TO THIS MANUFACTURER WERE WITHOUT PRODUCT EVENT INFORMATION TO IDENTIFY THEM. MEDWATCH 1045254-2012-00095 WAS FILED ON (B)(4), 2012, WITH THE PRODUCT ANALYSIS OF THE RETURNED BLADES. IN THE ORIGINAL MEDWATCH FOR THIS PRODUCT EVENT IT WAS REPORTED THERE WAS NO RETURN OF PRODUCT. THIS SUPPLEMENTAL MEDWATCH IS TO REPORT A PRODUCT ANALYSIS FOR THE RETURNED PRODUCT THAT APPEARS, THROUGH OUR INVESTIGATION, TO BE FOR THIS PRODUCT EVENT. (B)(4). PRODUCT ANALYSIS ENTERED BY QUALITY ENGINEER ON (B)(4), 2012- TWO ITEMS WERE RETURNED IN UNMARKED PLASTIC BAGS. THE FIRST SAMPLE WAS RETURNED WITH A PORTION OF THE ORIGINAL INNER POUCH AND LABELING, IDENTIFYING THE SAMPLE AS ITEM # 1884016HR RAD 60 BLADE 4MM, LOT# H7661102. THE SPIRAL WRAP WAS CLEARLY OBSERVABLE TO BE HYPER EXTENDED AND PARTIALLY UNWOUND. THE TIP WAS STILL ATTACHED AND THERE WAS NO MISSING MATERIAL. THE SAMPLE WAS BLOODY. THE HUBS WERE EXAMINED UNDER 20X MAGNIFICATION AND DAMAGE TO THE CHEVRONS WAS NOTED AS COULD LIKELY BE CAUSED BY THE HANDPIECE DRIVE MECHANISM. GROOVES ACROSS THE LOCKING AREA ON THE OUTER HUB COULD BE INDICATIVE OF THE COLLET ON THE HANDPIECE AS THE BLADE WAS IMPROPERLY LOADED AND DID NOT SPIN FREELY IN THE HANDPIECE. BOTH ARE INDICATIVE OF IMPROPER LOADING. CAUSE FOR IMPROPER LOADING IS NOT EVIDENT, AND IT IS UNKNOWN WHETHER THE IMPROPER LOADING WAS CAUSE FOR THE HYPEREXTENSION OF THE INNER BLADE SPIRAL WRAP. THE SECOND ITEM WAS RETURNED WITH A PORTION OF THE INNER POUCH AND LABELING IDENTIFYING THE UNIT TO BE FROM THE SAME LOT AS THE PREVIOUS SAMPLE. THE SAMPLE WAS BLOODY, BUT HAD NO APPARENT DEFECTS. THE BLADE WAS IN GOOD CONDITION AND SPUN FREELY WITHIN THE OUTER BLADE SHAFT. WHEN VIEWED UNDER 20X MAGNIFICATION, NO ANOMALIES WERE OBSERVED ON THE HUB. (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED SINUS PROCEDURE A BLADE BROKE DURING USE OF A POWERED DEBRIDER. THERE WERE FRAGMENTS IN THE PATIENT THAT THE SURGEON WAS ABLE TO FULLY REMOVE AND THERE WAS NO PATIENT IMPACT. THE WHOLE TIP UNRAVELED AND SPLIT APART. THE SURGEON WAS ABLE TO GRAB ANOTHER BLADE AND COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADE 1884016HR RAD60 4MM BUR, EAR, NOSE AND THROAT EQJ XOMED MFG JACKSONVILLE 1884016HR H7661102

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention