BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 9670502 · Received February 5, 2020

    Report

    Report Number
    9610614-2020-00002
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    January 3, 2020
    Report Date
    February 5, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE GENERATOR. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR THE DEVICE. NO ANOMALIES WERE FOUND IN THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED UPON THE REPORTED INFORMATION, IT APPEARS THAT THE PATIENT CONDITION OF HAVING AN ADHESION OF THE ILEUM TO THE ABDOMINAL WALL WAS A KEY FACTOR IN THE EVENT. HOWEVER, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE ESU WAS USED WITH MONOPOLAR INSTRUMENTS IN A LAPAROSCOPIC CHOLECYSTECTOMY (NOTE: MEDICAL PERSONNEL REPORTED THAT THERE ESU FUNCTIONED PROPERLY.). ONE DAY AFTER THE PROCEDURE, IT WAS DISCOVERED THAT THE BOWEL (ILEUM) WAS PERFORATED. THEREFORE, A LAPAROTOMY WITH AN ILEUM SEGMENT RESECTION WAS PERFORMED TO ADDRESS THE ISSUE. AN EXTENDED HOSPITAL STAY FOLLOWED. THE EVENT WAS INVESTIGATED FURTHER BY THE MEDICAL PROFESSIONALS AT THE FACILITY. PER THE PROFESSIONALS, THE PATIENT HAD INTRA-ABDOMINAL ADHESIONS (AFTER A FORMER OPEN SURGICAL APPENDECTOMY IN THE RIGHT LOWER ABDOMEN) AND SPECIFICALLY THERE WAS AN ADHESION OF THE ILEUM TO THE ABDOMINAL WALL. WHEN DIATHERMY WAS APPLIED DURING THE CHOLECYSTECTOMY, CURRENT AS EXPECTED/DESIGNED FLOWED TO THE RETURN ELECTRODE. HOWEVER, THE CURRENT HEATED THE ILEUM ADHESION WHICH RESULTED IN A THERMAL NECROSIS AND THE SUBSEQUENT PERFORATION. NOTE: THE ESU WAS DISTRIBUTED BY OUR PARENT COMPANY (ERBE ELEKTROMEDIZIN (B)(4)) TO A (B)(6) MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134450 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R