BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS® BLADE

    MDR report key: 5144980 · Received October 13, 2015

    Report

    Report Number
    1045254-2015-00333
    Event Type
    Injury
    Date Received
    October 13, 2015
    Date of Event
    September 13, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 09/18/2015. DESCRIBE EVENT PROBLEM: ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THIS PROCEDURE WAS A SINUS SURGERY FOR NASAL POLYPS AND INFLAMMATION. THE DEVICE WAS RUN IN REVERSE MODE AT 5000 RPM. DATE RECEIVED BY MANUFACTURER: 02/22/2016. NOTE: PER THE PRODUCT CATALOG: THE BLADE OPERATING SPEED IS 5000 RPM IN OSCILLATE MODE / DIRECTION.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT EVALUATION: FOR ANALYSIS, 2 UN-SEALED SAMPLES, PART NUMBER 1884005, FROM LOT NUMBER 0209773942 WERE RECEIVED; THERE WAS EVIDENCE OF BIOLOGICAL CONTAMINANTS [BASED OFF OF THE REACTIVITY WITH HYDROGEN PEROXIDE]. WHEN COMPARED TO THE ASSEMBLY DRAWINGS: VISUALLY THE INNER DISTAL TIP WAS BROKE OFF OF BOTH SAMPLES WHICH WOULD HAVE RESULTED IN THE REPORTED EVENT. THE TIP WAS RETURNED FOR SAMPLE 1 AND IT MEASURED 0.223¿ IN LENGTH. THE PORTION THAT BECAME DETACHED ON SAMPLE 2 WOULD HAVE MEASURED APPROXIMATELY 0.20¿ AND WAS NOT RETURNED. THE INNER SHAFT OF BOTH SAMPLES WAS GOUGED 0.57¿ / 0.59¿ FROM THE DISTAL FACE OF THE INNER HUB WHICH CORRESPONDS TO THE PROXIMAL END OF THE OUTER TUBE IN THE FRONT HUB INDICATING METAL ON METAL CONTACT / CHAFING. THERE WAS ADDITIONAL GOUGING OF THE INNER SHAFT ON BOTH SAMPLES JUST PROXIMAL TO THE BREAK POINT OF THE TIP. THE INNER TUBE OF SAMPLE 2 HAD A PIECE INSIDE CONSISTENT WITH BONE JUST PROXIMAL TO THE BREAK POINT. THE CUSTOMER INDICATED THERE WERE NO ISSUES WITH THE DEVICE BEFORE USE; THE TIP BROKE WHEN THE DOCTOR WAS CUTTING. THE INFORMATION INDICATES EXCESS PRESSURE WAS APPLIED DURING USE WHICH CAUSED THE INNER SHAFT AND OUTER TUBE TO RUB TOGETHER RESULTING IN THE GOUGING, AND BREAKAGE. THE INSTRUCTIONS FOR USE WARN THAT EXCESSIVE PRESSURE APPLIED TO A BUR/BLADE MAY CAUSE A FRACTURE. NOTE: [EXCESS: EXCEEDED SUFFICIENT PRESSURE REQUIRED FOR OPERATION].

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: IT WAS CONFIRMED THAT THIS PROCEDURE WAS A SINUS SURGERY FOR NASAL POLYPS AND INFLAMMATION. THE DEVICE WAS RUN IN REVERSE MODE AT 5000 RPM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A SURGERY FOR SINUSITIS, "IT WASN'T FOUND ANY ABNORMALITY BEFORE SURGERY TEST. THE NEW BLADE WAS BROKEN DURING USE. THE DOCTOR REPLACED A NEW BLADE TO FINISH THE SURGERY. IT IS EFFECTIVE. PATIENT HAS NO IMPACT." ADDITIONAL INFORMATION CONFIRMS THAT "IT WAS FOUND THE TIP OF BLADE IS MISSING WHEN THE DOCTOR WAS CUTTING. THE HOSPITAL GAVE THE CONCLUSION THAT THERE IS NO FRAGMENT LEFT IN PATIENT'S BODY AFTER CT CHECK. NOW THE PATIENT IS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677311 XPS® BLADE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884005 0209773942

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention