BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCISION

    MDR report key: 528484 · Received May 11, 2004

    Report

    Report Number
    528484
    Event Type
    Other
    Date Received
    May 11, 2004
    Date of Event
    January 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    ENCISION, INC.
    Product Code
    FHB
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT HAD AN INITIAL LAPAROTOMY CHOLECYSTECTOMY PROCEDURE IN 2004 AND WAS DISCHARGED THE NEXT DAY. THE PT RETURNED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF ABDOMINAL PAIN AND THE PT WAS MEDICATED. EXPLORATORY LAPAROTOMY WAS PERFORMED WHICH DID NOT IDENTIFY SOURCE OF PT'S ABDOMINAL PAIN. THE PT WAS PRESENTED TO ANOTHER FACILITY IN THE SYSTEM SEVERAL DAYS LATER WITH COMPLAINTS OF PAIN. SURGERY REVEALED A BILE DUCT INJURY RIGHT HEPATIC DUCT THAT APPEARED TO BE CAUTERY INJURY, CAUSING BILE TO COLLECT IN THE ABDOMEN. THE INJURY WAS A CIRCULAR AREA THAT APPEARED TO BE A BURN. NO FURTHER DETAILS ARE AVAILABLE ON THE BURN. IT WAS DETERMINED THAT THE PULLER AND THE GRASPER ARE USED INTERCHANGABLY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCISION HOOK FHB ENCISION, INC. ES-3512B *
    2 ELECTROSHIELD ELECTROSCOPE HANDPIECE WITH PULLER GEI CONMED ELECTROSURGERY ES57005 *
    3 SPLASHRPOOF ELECTROSURGICAL FOOTSWITCH FOOT PEDAL GEI CONMED ELECTROSURGERY * *
    4 * AEM MONITOR - BIPOLAR GENERATOR GEI ENCISION, INC. EM2TA *
    5 EXCALIBUR ELECTROSURGICAL DEVICE GEI CONMED ELECTROSURGERY 60-5200-001 *
    6 ENCISION ELECTRIC CORD GEI CONMED ELECTROSURGERY ES4007 *
    7 ELECTROSHIELD ELECTROSCOPE HANDPIECE WITH SCISSORS GEI CONMED ELECTROSURGERY ES-57005 *
    8 * SCISSOR INSERT FHB ENCISION, INC. ES-0001 *
    9 * TAPPERED MARYLAND DISSECTOR FHB ENCISION, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other ELECTROSHIELD/ELECTROSCOPE-HANDPIECE WITH SCISSORS| 1. BIPOLAR GENERATOR-AEM "ENCISION" MONITOR| ELECTROSHIELD/ELECTROSCOPE-HANDPIECE WITH PULLER,| CORD.| SPLASHPROOF ELECTROSURGICAL FOOTSWITCH "ENCISION"| "EXCALIBUR" ELECTROSURGICAL UNIT, "ENCISION" HOOK.