BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 807510 · Received January 18, 2007

    Report

    Report Number
    1717344-2007-00019
    Event Type
    Injury
    Date Received
    January 18, 2007
    Date of Event
    January 2, 2007
    Report Date
    January 8, 2007
    Manufacturer
    VALLEYLAB QA
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS ALWAYS A CONCERN WHEN VALLEYLAB IS NOTIFIED OF A PRODUCT COMPLAINT. WE AS A MFR STRIVE FOR EXCELLENCE IN CONSTANTLY IMPROVING OUR PRODUCTS QUALITY AND SURGICAL CARE. A MORE COMPLETE DESCRIPTION OF THE INCIDENT DESCRIBED IN THE RECEIVED REPORT INCLUDING RELEVANT EVENTS PRIOR TO AND SUBSEQUENT TO THE ACTUAL INCIDENT HAS BEEN SOUGHT (INCLUDING ADD'L PT STATUS DETAILS). THE FILE WILL BE UPDATED WHEN ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    PROCEDURE AND PT SEX: NOT REPORTED. REPORTEDLY, THE INSTRUMENT BROKE DURING UTILIZATION; A SMALL SCREW FROM THE JAWS SUPPORT IS MISSING; THE PT WAS X RAYED, BUT THE SCREW COULD NOT BE FOUND. THE PART WAS POTENTIALLY LEFT IN THE PT ALTHOUGH IT HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER ELECTROSURGICAL DEVICE GEI VALLEYLAB QA * 107447

    Patients

    Seq Age Sex Outcome Treatment
    1 YR