BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE HS XTD DISP ELEC/CORD

    MDR report key: 2962990 · Received January 23, 2013

    Report

    Report Number
    1717344-2013-00042
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 19, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SNAP DAMAGE CAN BE CAUSED BY THE USER IMPROPERLY MISALIGNING THE SNAPS INTO THE MATING HOLES DURING ASSEMBLY. THIS DAMAGE CAN ALSO BE CAUSED BY MULTIPLE ASSEMBLY ATTEMPTS. THE INSTRUCTIONS FOR USE PROVIDE ADD'L INFO ON THE PROPER METHOD OF ASSEMBLING THE ELECTRODES INTO THE REUSABLE INSTRUMENT. MFG PERFORMS A 100% VISUAL INSPECTION THAT INCLUDES CHECKING FOR DAMAGE TO THE SNAPS. IT IS UNLIKELY THE DEVICE LEFT THE COVIDIEN FACILITY IN THIS CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AT FIRST SEALING ON PT, THE RE-GRASP ALARM OCCURRED REPEATEDLY AND COULD NOT COMPLETE THE SEALING. NO PT HARM AND NOTHING FELL INTO THE CAVITY. THE DEVICE WAS RETURNED WITH TWO BROKEN AND MISSING SNAP PINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33285 LIGASURE HS XTD DISP ELEC/CORD LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK