BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 14159640 · Received April 20, 2022

    Report

    Report Number
    9610614-2022-00011
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 23, 2022
    Report Date
    April 20, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED (THE NON-ERBE KNIFE ELECTRODE WAS NOT AVAILABLE FOR AN EVALUATION.). 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 FUNCTIONING 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 EVENT. BASED UPON THE PROVIDED INFORMATION, NO DETERMINATION COULD BE MADE AS TO WHAT CAUSED THE FLASH BURN AND/OR PROGRESSION OF THE PATIENT'S INJURY. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A PROCEDURE TO REMOVE AN INGROWN TOE NAIL ON A PATIENT'S BIG TOE. THE ESU WAS USED WITH A NON-ERBE INSTRUMENT (A KNIFE ELECTRODE) AND NEUTRAL ELECTRODE. NO INFORMATION WAS PROVIDED IN REGARDS TO THE UNIT'S SETTINGS. INITIALLY, IT WAS REPORTED THAT THERE NO VISUAL TISSUE EFFECT, BUT THEN A 5 SECOND COAGULATION WAS APPLIED TO "STERILIZE THE NAIL MATRIX". AT THE END OF THE PROCEDURE, A SMALL 2 MM BURN WAS OBSERVED ON THE PATIENT'S SKIN. THE MEDICAL STAFF WAS NOT CONCERN WITH THE NECROSIS AND, AS PLANNED, THE PATIENT WAS DISCHARGED. LATER, THE CONDITION OF THE BURN/WOUND ON THE PERIUNGUAL SKIN DETERIORATED AND SUBSEQUENTLY IT WAS CONSIDERED AS A 3RD DEGREE BURN. THE LESION RESEMBLED AN ARC FLASH BURN WITH ENTRY AND EXIT POINTS (NOTE: THE NON-ERBE KNIFE ELECTRODE HAD A PLASTIC SLEEVE AT ITS PROXIMAL END TO PREVENT ARCING AND AVOID THIS TYPE OF BURN). NEVERTHELESS, THE NECROSIS WAS SURGICALLY REMOVED. THEN, ANTIBIOTIC THERAPY WAS ADMINISTERED AND AN ATTEMPT WAS MADE TO COVER THE EXPOSED BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719379 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Unknown Required Intervention| H