BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOOK CEV230-1 DIA 5MM MONOPOLAR PERISSAT

    MDR report key: 7281952 · Received February 20, 2018

    Report

    Report Number
    2523190-2018-00027
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    December 8, 2018
    Report Date
    January 23, 2018
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    GEI
    PMA / PMN Number
    K993655
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED ON 30 JAN 2018. DURING THEIR INVESTIGATIONS, THE SERVICE AND REPAIR TECHNICIANS FOUND ELECTRICAL DEFECT IN INSULATING SHEATH. THE ELECTRICAL DEFECT ON THE INSULATING SHEATH IS LIKELY DUE TO IMPACT IN THE TUBE. THE SPECIFIC LOT NUMBER OF THE AFFECTED PRODUCT WAS NOT PROVIDED; HOWEVER A RANGE OF POTENTIAL LOTS WAS PROVIDED (1881917, 130501, 2176907, 150301, 250540). REVIEW OF THESE LOTS FOUND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT. THE MANUFACTURING DATE FOR THE POTENTIAL LOTS WERE 17JAN2017, 31MAY2013, 13JUN2017, 23MAR2015, 16FEB2016. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018 DURING THE HEMOSTASIS PORTION OF A SURGERY, AN ELECTRIC ARC ON PART OF THE HOOK RESULTED IN BURN OF THE HEPATIC DUCT OF THE PATIENT. A SECOND SURGERY WAS NECESSARY ON (B)(6) 2017 DUE TO BILIARY PERITONITIS POTENTIALLY LINKED TO THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124877 HOOK CEV230-1 DIA 5MM MONOPOLAR PERISSAT PFM16 GEI INTEGRA MICROFRANCE S.A.S. 1881917

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention