BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 3970197 · Received April 29, 2014

    Report

    Report Number
    3006451981-2014-00612
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 15, 2014
    Manufacturer
    COVIDIEN LLC (SHANGAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT ACTIVATE. NO TISSUE DAMAGE. NO PATIENT INJURY. THE SURGICAL TIME WAS EXTENDED GREATER THAN 30 MINUTES DUE TO THE SITE HAVING TO GET ANOTHER DEVICE FROM A NEIGHBORING HOSPITAL WHILE THE PATIENT REMAINED UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256115 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGAI) S2MB01X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK