BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER ENDOSCOPY

    MDR report key: 34553 · Received May 7, 1996

    Report

    Report Number
    34553
    Event Type
    Malfunction
    Date Received
    May 7, 1996
    Date of Event
    April 12, 1996
    Report Date
    April 22, 1996
    Manufacturer
    STRYKER ENDOSCOPY DIV. STRYKER CORP.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS USING THE MICRODEBRIDER ON AN ENDOSCOPIC SINUS SURGERY. WHEN IT WAS TIME TO USE THE MICRODEBRIDER IT WOULD NOT FUNCTION. PHYSICIAN DETERMINED THAT HE COULD NOT DO THE PROCEDURE WITHOUT THE MICRODEBRIDER. HE CANCELLED THE CASE. PT WAS AWAKEN FROM ANESTHESIA AND TAKEN TO THE RECOVERY ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER ENDOSCOPY MICROBRIDER SPLEEN CONSOLE KOG STRYKER ENDOSCOPY DIV. STRYKER CORP. 266-602-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other