BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 6176274 · Received December 15, 2016

    Report

    Report Number
    1717344-2016-01163
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 22, 2016
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    PMA / PMN Number
    K150835
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 12/14/2016. THE INCIDENT SAMPLE WAS 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE WITHOUT ANY OBSERVED ISSUES. HOWEVER, THE PATIENT EXPERIENCED ABDOMINAL BLEEDING AFTER THE OPERATION. THE ABDOMEN WAS DRAINED AND THE PATIENT¿S BLOOD PRESSURE WAS LOWERED TO STOP THE BLEEDING. A BLOOD TRANSFUSION WAS NOT REQUIRED. BOTH THE OPERATION AND REOPERATION TOOK PLACE WITHIN THE SAME DAY, AND THE PATIENT IS NOW IN GOOD CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER HAS ALSO REPORTED THAT THEY BELIEVE ONE OF THE SEALS PERFORMED BY THE DEVICE MAY HAVE REOPENED, CAUSING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829620 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF5544

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R