BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO RECIPROCATING SAW

    MDR report key: 3842535 · Received June 2, 2014

    Report

    Report Number
    0001811755-2014-01993
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEER REPORTED THAT THE HANDPIECE RAN WITHOUT USER ACTIVATION AND HAD A CORRODED MOTOR CARTRIDGE.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS IN PROGRESS; ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE AT THE USER FACILITY THE MICRO RECIPROCATING SAW WAS ABLE TO RUN IN THE STOP POSITION. AS THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE AT THE USER FACILITY, THE MICRO RECIPROCATING SAW WAS ABLE TO RUN IN THE STOP POSITION. AS THERE WAS NO PROCEDURE ASSOCIATED WITH THIS EVENT, THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320966 MICRO RECIPROCATING SAW DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1