BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATRED GRASPER

    MDR report key: 5008393 · Received August 12, 2015

    Report

    Report Number
    3007208013-2015-00018
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 10, 2015
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 07/14/2015 ALL DEVICES WITH (B)(4) FROM INVENTORY WERE INSPECTED FOR ANY FRACTURES OR CRACKS IN THE TIPS. THERE WERE NO FRACTURES OR CRACKS IN THE DEVICES IN INVENTORY. ALL DEVICES IN INVENTORY FROM LOT NUMBER 00122271 WERE EXAMINED. NO OTHER REPORTED INCIDENTS/COMPLAINTS FOR (B)(4).

    Description of Event or Problem · 1

    FENESTRATRED GRASPER LONG LIMITED USE SLOTTED WITH MICRO SERRATIONS (B)(4)), TIP OF THE GRASPER BROKE OFF DURING A PROCEDURE AND THE TIP WAS REMOVED FROM THE PATIENT WITH NO ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530524 FENESTRATRED GRASPER FENESTRATRED GRASPER LONG LIMITED USE SLOTTED WITH MICRO SERRATIONS 5.BX LXH SYMMETRY SURGICAL INC. 3261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other