BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE VIO 300 D

    MDR report key: 12438098 · Received September 8, 2021

    Report

    Report Number
    9610614-2021-00017
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 24, 2021
    Report Date
    September 8, 2021
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ERBE ESU, VEM, AND MONOPOLAR CABLE WERE THOROUGHLY INSPECTED/TESTED. THE FINDINGS ARE AS FOLLOWS: ESU: THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES AND A POWER OUTPUT CHECK. THE GENERATOR WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. VEM: THE UNIT WAS FOUND TO BE FUNCTIONING AS INTENDED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES AND A POWER OUTPUT CHECK. THE EXTENSION MODULE WAS/IS WITHIN SPECIFICATIONS AND ALL FEATURES WERE/ARE WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DHR OF THE INVOLVED DEVICE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. MONOPOLAR CABLE: AN INSPECTION OF THE CABLE SHOWED THAT, IMMEDIATELY AFTER THE KINK (SLEEVE) PROTECTION, IT HAD BURNED THROUGH AT THE CONNECTOR ON THE INSTRUMENT SIDE. THERE WERE SIGNS OF MELTING OF THE CABLE STRANDS AND OF THE SILICONE SHEATH (A MATERIAL/MANUFACTURING DEFECT WAS NOT APPARENT). THERE ARE MANY POSSIBLE FACTORS INVOLVED WITH THIS TYPE OF ISSUE. THE CABLE COULD HAVE BEEN DAMAGED (DUE TO WEAR, STRESS, ETC.) PRIOR TO USE, THERE WAS MOISTURE (POSSIBLY FROM A FLAMMABLE DISINFECTANT) INSIDE THE CABLE'S CONNECTOR, ETC. PER THE ACCESSORY'S NOTE ON USE (NOU), THE USER IS REQUIRED TO INSPECT THE CABLE FOR ANY VISIBLE DAMAGE AND PERFORM CONTINUITY TESTING TO MAKE SURE THAT IT IS FUNCTIONING PROPERLY BEFORE USE. ALSO, PER THE NOU, ACCESSORIES ARE TO BE DRY PRIOR TO ANY ACTIVATION. NEVERTHELESS, NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A SIGMA SURGERY WITH DAVINCI. THE ESU WAS USED WITH AN ERBE VIO EXTENSION MODULE [VEM, PART NUMBER (P/N) 10141-000, SERIAL NUMBER (B)(4)], AS WELL AS A MONOPOLAR CABLE, MO 9/5, 4 MM SOCKET, LENGTH 4 M (P/N 20192-104, LOT NUMBER 0719). A RETURN ELECTRODE FROM (B)(6) (TYPE UNKNOWN) WAS ATTACHED TO THE RIGHT THIGH OF THE PATIENT. ANY OF THE OTHER ACCESSORIES USED (E.G., ACTIVE ELECTRODE ETC.) WERE NOT REPORTED TO ERBE. THE MODE USED WAS UNKNOWN BUT EFFECT 4 AND EFFECT 5 (POWER LIMITATION PER 100 WATTS) WAS EMPLOYED. DURING USE, THERE WAS BREACH ON THE INSTRUMENT-SIDE CONNECTOR OF THE MONOPOLAR CABLE WHICH RESULTED IN A FLAME AND FIRE TO THE PATIENT'S COVER. THE FIRE WAS IMMEDIATELY EXTINGUISHED. AN INSPECTION OF THE COVER REVEALED A 15 CM X 15 CM BURN HOLE IN THE COVER ON THE RIGHT SIDE OF THE PATIENT. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337355 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other