BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER 100 COMMAND RECIPROCATING SAW

    MDR report key: 29955 · Received January 17, 1996

    Report

    Report Number
    29955
    Event Type
    Injury
    Date Received
    January 17, 1996
    Date of Event
    November 29, 1995
    Report Date
    January 10, 1996
    Manufacturer
    STRYKER INSTRUMENTS DIV. STRYKER CORP.
    Product Code
    DZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING USE, RECIPROCATING SAW LEAKED BLACK FLUID INTO PT'S ORAL CAVITY. INSTRUMENT WAS REMOVED FROM FIELD AND SENT TO BIOMEDICAL ENGINEERING FOR EVALUATION. PT'S ORAL CAVITY WAS IRRIGATED WITH 1000 CC OF SALINE. PROCEDURE WAS COMPLETED. PT WAS IN STABLE CONDITION. AT POST-OP, NO INFECTION; NO SEQUELAE FROM INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER 100 COMMAND RECIPROCATING SAW DENTAL SAW DZH STRYKER INSTRUMENTS DIV. STRYKER CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention