BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMB ELECTRIC SAGITTAL SAW

    MDR report key: 8623620 · Received May 20, 2019

    Report

    Report Number
    0001811755-2019-01754
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    May 10, 2019
    Report Date
    May 20, 2019
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    UDI-DI
    07613154938292
    PMA / PMN Number
    K112593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER SERVICE TECHNICIAN REPORTED THAT THE DEVICE OVERHEATED WHILE IT WAS BEING SERVICED AT THE USER FACILITY. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418102 REMB ELECTRIC SAGITTAL SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO 07613154938292

    Patients

    Seq Age Sex Outcome Treatment
    1