BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 5412515 · Received February 5, 2016

    Report

    Report Number
    3006451981-2016-00114
    Event Type
    Malfunction
    Date Received
    February 5, 2016
    Date of Event
    February 4, 2016
    Report Date
    February 5, 2016
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (B)(4). DATE OF INITIAL REPORT : 02/05/2016. DATE OF FOLLOW-UP REPORT #1 : 04/05/2016. DATE OF FOLLOW-UP REPORT #2 : 04/05/2016.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT : 02/05/2016. DATE OF FOLLOW-UP REPORT : 04/05/2016. ONE USED LS1500 WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND ESCHAR IN THE KNIFE TRACK. THE CUSTOMER REPORTED THAT AFTER A FEW TIMES OF SEALING, THE KNIFE TRIGGER DID NOT RETURN AND JAWS DID NOT OPEN. THE JAWS WERE OPENED MANUALLY AND RELEASED FROM THE TISSUE. THE REPORTED CONDITION WAS CONFIRMED. INSPECTION NOTED ESCHAR BETWEEN THE JAWS. THE BLADE DID NOT MOVE SMOOTHLY AS THE TRIGGER WAS RETRACTED TO ADVANCE THE BLADE. AFTER CLEANING, THE KNIFE MOVED SMOOTHLY ALONG THE KNIFE TRACK AND RETURNED TO HOME POSITION WITHOUT ASSISTANCE. THE KNIFE CUT WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE ATTRIBUTED TO THE USER INFREQUENTLY CLEANING THE JAWS DURING USE ALLOWING TISSUE AND BLOOD TO BUILD UP. THE IFU RECOMMENDS CLEANING THE JAWS WITH A PIECE OF WET GAUZE OFTEN TO HELP MINIMIZE TISSUE BUILD UP BETWEEN THE JAWS. THE IFU INSTRUCTS THE USER TO OPEN THE JAWS BY PUSHING FORWARD ON THE WHITE MOVABLE HANDLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY AND SALPINGECTOMY, THE DEVICE KNIFE DID NOT RETRACT AND THE JAWS COULD NOT BE RE-OPENED WHILE APPLIED TO TISSUE. THE SURGEON REMOVED THE JAWS MANUALLY WITH NO PATIENT INJURY OR TISSUE DAMAGE. ANOTHER DEVICE OF THE SAME TYPE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70956 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN LS1500 S5GB014X

    Patients

    Seq Age Sex Outcome Treatment
    1