BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 5345329 · Received January 5, 2016

    Report

    Report Number
    1045254-2016-00002
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 11, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT ANALYSIS FOUND 1 UN-SEALED SAMPLE, PART NUMBER 1884005, FROM LOT NUMBER 0209773942 RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. THE FINISH GOODS PACKAGING WAS NOT RETURNED. WHEN COMPARED TO THE ASSEMBLY DRAWING: VISUALLY, THE INNER BLADE WAS ALREADY DISASSEMBLED FROM THE OUTER WHEN RECEIVED AND A PORTION OF THE INNER TIP WAS MISSING WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE INFORMATION MAY INDICATE IT CAME IN CONTACT WITH AN UNAPPROVED MATERIAL. THE PORTION THAT BECAME DETACHED WAS NOT RETURNED HOWEVER BASED OFF THE REMAINDER OF THE ASSEMBLIES THE PIECE WOULD HAVE MEASURED APPROXIMATELY 0.17¿ IN LENGTH BY 0.13¿ IN DIAMETER WHICH CORRESPONDS TO THE FIRST PROXIMAL VALLEY OF THE INNER TEETH. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE ABRASIONS / STRIATIONS ON THE SHAFT OF THE INNER ASSEMBLY 0.57¿ FROM THE DISTAL FACE OF THE INNER HUB AND JUST PROXIMAL TO THE BREAK ON THE INNER AND OUTER ASSEMBLIES (WHICH MAY INDICATE EXCESS PRESSURE WAS APPLIED DURING USE). THE DEFORMATION OF THE BREAK IS CONSISTENT WITH DAMAGE OCCURRING WHILE SPINNING IN A CLOCKWISE DIRECTION. INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE AND THAT THE DEVICE IS USED FOR THE RESECTION OF SOFT TISSUE AND BONE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION]. IT WAS REPORTED THAT THE PRODUCT CHECKED OK BEFORE USE HOWEVER THIS DOES NOT NECESSARILY RULE OUT MANUFACTURING AS A POTENTIAL CAUSE. BASED OFF OF THE CONDITION OF THE RETURNED DEVICE AND AVAILABLE EVIDENCE; MISUSE / MISHANDLING, MANUFACTURING, OPERATIONAL FACTORS / OPERATIONAL CONTEXT AND SUPPLIER CANNOT BE RULED OUT AS POTENTIAL CAUSES.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS USED DURING A BILATERAL ENDOSCOPIC PROCEDURE TO TREAT NASAL POLYPS AND INFLAMMATION, IN REVERSE MODE, AT 5,000 RPM WHEN IT BROKE. THE BLADE WAS BEING USED ON SOFT TISSUE WHEN IT BROKE. THE NEW INFORMATION WAS RECEIVED ON FEB. 22, 2016. THE NEW INFORMATION INDICATES THAT THE DEVICE WAS BEING USED IN REVERSE MODE. PER THE IFU, THE DEVICE SHOULD BE USED IN OSCILLATE MODE ONLY. THEREFORE, THE CONCLUSION CODE IS CHANGED TO "USE ERROR CAUSED OR CONTRIBUTED TO EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT UNDERWENT BILATERAL ENDOSCOPIC SURGERY. THE PRODUCT WAS CHECKED AND WAS OKAY BEFORE USE. IN SURGERY, THE BLADE WAS BROKE. THERE IS NO PATIENT IMPACT. THE DOCTOR REPLACED A NEW BLADE TO COMPLETE THE SURGERY. THERE WAS NO FRAGMENT REMAINING IN PATIENT'S BODY AFTER CT SCAN. THE SURGERY WAS DELAYED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: THE DEVICE WAS USED DURING A BILATERAL ENDOSCOPIC PROCEDURE TO TREAT NASAL POLYPS AND INFLAMMATION, IN REVERSE MODE, AT 5,000 RPM WHEN IT BROKE. THE BLADE WAS BEING USED ON SOFT TISSUE WHEN IT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5198 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0209773942

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention