BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 8513569 · Received April 15, 2019

    Report

    Report Number
    8513569
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 12, 2019
    Report Date
    April 4, 2019
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    MNK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FROM STAFF: PATIENT HAD DOCUMENTED BONDED FRONT TOOTH PRIOR TO PROCEDURE ON THE ANESTHESIA RECORD. WHEN PATIENT WOKE FROM PROCEDURE SHE INFORMED RECOVERY NURSE THAT HER TOOTH WAS BROKEN. CERTIFIED REGISTERED NURSE ANESTHETIST AND PROCEDURE DOCTOR WERE INFORMED AND CAME TO POST OP AND EXAMINED AND SPOKE TO PATIENT. CHARGE NURSE AND DEPARTMENT HEAD WERE AWARE. PATIENT STATED THAT HER TOOTH HAD BEEN REPAIRED SEVERAL YEARS AGO. PATIENT HAD A BITE BLOCK INSERTED BEFORE THE ESOPHAGOGASTRODUODENOSCOPY, THE SCOPE INSERTED THROUGH THE BITE BLOCK AND THE BITE BLOCK TAKEN OUT AFTER THE PROCEDURE. PATIENT TAKEN TO POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306718 OLYMPUS ENDOSCOPIC BITE BLOCK MNK OLYMPUS SURGICAL TECHNOLOGIES AMERICA MAJ-1632

    Patients

    Seq Age Sex Outcome Treatment
    1 18250 DA