BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE - INDIGO¿ DRILL

    MDR report key: 13232073 · Received January 11, 2022

    Report

    Report Number
    1045254-2022-00017
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    June 10, 2021
    Report Date
    January 11, 2022
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: ONE OF THE FOLLOWING HANDPIECES WAS ALLEGED BY THE CUSTOMER TO HAVE OVERHEATED BUT COULD NO LONGER IDENTIFY WHICH ONE: 1. PRODUCT: 1845000, S/N:(B)(4). PRODUCT: 1845000, S/N:(B)(4) BOTH HANDPIECES WERE SENT FOR REPAIR AND ANALYSIS ARE FOUND BELOW. H3: PRODUCT: 1845000, S/N:(B)(4) MFG DATE: NI ANALYSIS FOUND THAT THE MOTOR KICKSTARTS AND SOUNDS ROUGH. THE COLLET SOUNDS ROUGH. THE MOTOR AND COLLET HAVE BEEN REPLACED. THE DEVICE HAS BEEN TESTED ACCORDING TO SPECIFICATIONS. PRODUCT: 1845000, S/N:(B)(4) MFG DATE: 11-13-2018 ANALYSIS FOUND THAT THE HANDPIECE WAS RECEIVED IN GOOD CONDITION. NO ANOMALIES HAVE BEEN FOUND. THE FDM 10 IS APPLICABLE FOR BOTH HANDPIECES. THE FDR C0601 AND D02 ARE APPLICABLE FOR S/N:(B)(4). THE FDR C19 AND D14 ARE APPLICABLE FOR S/N:(B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    A HEALTH CARE PROVIDER REPORTED THAT THE DRILL WAS USED AND WAS INITIALLY GETTING HOT BUT HCP GAVE THE BUR A WIGGLE WHICH SEEMED TO SORT IT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802634 IPC® HANDPIECE - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MEDTRONIC XOMED INC. 1845000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown