BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XPS BLADE

    MDR report key: 11913137 · Received June 1, 2021

    Report

    Report Number
    9612501-2021-00873
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 5, 2021
    Report Date
    June 1, 2021
    Manufacturer
    COVIDIEN LLC
    Product Code
    EQJ
    UDI-DI
    00763000036782
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE 2 DEVICES USED IN THE SURGERY AND WE'RE SUBMITTING 2 MDRS FOR THE SAME EVENT LIST OF PRODUCTS INVOLVED: BLADE,SILVER BULLET,2.9MM,M4 ROTAT,W/IRR LOT NO. 221527812 BLADE,SILVER BULLET,2.9MM,M4 ROTAT,W/IRR LOT NO. 221527812. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTH CARE PROFESSIONAL THAT A SILVER BULLET BLADE WAS USED TO TRIM THE SINUS TURBINATE AND THE PIECE INSIDE THE BLADE BROKE OFF. THEY REPLACED WITH ANOTHER BLADE WITH THE SAME LOT NUMBER AND IT BROKE AS WELL. AN X RAY WAS DONE AS PROTOCOL AT THE END OF THE CASE TO MAKE SURE NOTHING WAS IN THE NOSE; IT WAS CONFIRMED THAT NOTHING REMAINED IN THE NOSE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S) WITH 30MINS DELAY. THERE WAS NO PATIENT IMPACT. UPON FOLLOW UP IT WAS REPORTED THAT X-RAY WAS DONE SPECIFICALLY TO CHECK FOR FRAGMENTS. THE PART OF THE BLADE THAT BROKE WAS DISTAL TIP. THERE WERE FRAGMENTS DETACHED FROM THE BROKEN BLADE THAT FELL INTO THE PATIENT. THE ANESTHESIA HAD TO DELAY WAKING THE PATIENT UP SO AN X-RAY COULD BE PERFORMED TO MAKE SURE NO FRAGMENTS REMAINED IN THE SINUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812431 XPS BLADE BUR, EAR, NOSE AND THROAT EQJ COVIDIEN LLC 1882905HRE 0221527812 00763000036782

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention