BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEM SCISSORS, INSERT-5MM, REUSABLE, 3/4"

    MDR report key: 405774 · Received July 15, 2002

    Report

    Report Number
    1722040-2002-00005
    Event Type
    Injury
    Date Received
    July 15, 2002
    Date of Event
    June 26, 2002
    Report Date
    July 11, 2002
    Manufacturer
    ENCISION INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED ARCING FROM THE HOUSING OF THE LAPAROSCOPIC SCISSORS INSERT, DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE. REPORTER STATED A POP WAS HEARD AND A FLASH NOTED, AFTER WHICH A BOWEL INJURY WAS FOUND. SOME REPAIR WAS REQUIRED, EXTENDING THE PROCEDURE, BUT THE BOWEL WAS NOT PERFORATED. AFTER THE PROCEDURE A BLACK MARK WAS ALSO FOUND ON THE TROCAR CANNULA. THE ENCISION AEM HANDLE AND SCISSORS INSERT, ALONG WITH THE TROCAR, WERE RETURNED FOR EVAL. THE REPORTER EXPRESSED CONCERN THAT THE ENCISION AEM MONITOR HAD NOT INDICATED A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEM SCISSORS, INSERT-5MM, REUSABLE, 3/4" LAPAROSCOPIC SURGICAL INSTRUMENT COMPONENT GCJ ENCISION INC. ES00002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention