BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLASS VAN STAINLESS STEEL SURGICAL BLADE

    MDR report key: 2116592 · Received May 26, 2011

    Report

    Report Number
    1058382-2011-00001
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    March 4, 2011
    Report Date
    May 23, 2011
    Manufacturer
    M/S NIRAJ INDUSTRIES PVT. LTD.
    Product Code
    GES
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGICAL BLADE BECAME DETACHED FROM HANDLE DURING SURGICAL PROCEDURE AND FELL INTO THE BODY CAVITY. THE SURGICAL TEAM HAD TO LOCATE THE BLADE WITH X-RAY TO RECOVER THE BLADE FROM THE PATIENT WHICH PROLONGED THE SURGICAL PROCEDURE. NO REPORTED HARM CAME TO THE PATIENT AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLASS VAN STAINLESS STEEL SURGICAL BLADE BLADE, SURGICAL GES M/S NIRAJ INDUSTRIES PVT. LTD. 3001T-11 091610

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention