BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORBIT SYNOVATOR

    MDR report key: 1591926 · Received January 27, 2010

    Report

    Report Number
    1591926
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    January 27, 2010
    Report Date
    January 27, 2010
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THERE WAS RUST ON THE TIP OF THE SYNOVATOR AND IT WAS JAMMED AND WOULD NOT WORK. IT DID NOT ENTER THE PATIENT. MANUFACTURER RESPONSE (AS PER REPORTER) FOR 4.5MM ORBIT SYNOVATOR, ORBIT SYNOVATOR:REP CALLED AND NOTIFIED. AWAITING PACKAGING TO RETURN TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBIT SYNOVATOR CURVED BLADE GEI SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7205321 20180501

    Patients

    Seq Age Sex Outcome Treatment
    1 *