BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 350

    MDR report key: 12950634 · Received December 7, 2021

    Report

    Report Number
    9610614-2021-00022
    Event Type
    Injury
    Date Received
    December 7, 2021
    Date of Event
    November 26, 2021
    Report Date
    December 7, 2021
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU AS WELL AS THE MONOPLOAR HANDLES WERE RETURNED AND THOROUGHLY INSPECTED/ TESTED. THE FINDINGS WERE AS FOLLOWS: ESU 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. MONOPLAR HANDLES AN INSPECTION OF THE HANDLES DID NOT REVEAL ANY DEFECTS. THE HANDLES WERE IN GOOD CONDITION. IN CONCLUSION, THERE WERE NO ISSUES WITH THE ERBE EQUIPMENT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED UPON THE REPORTED INFORMATION AND THE INSPECTION/TESTING OF THE ERBE EQUIPMENT, IT APPEARS THAT THE DOCTOR, DURING ACTIVATION, CAME INTO DIRECT CONTACT WITH THE NON-ISOLATED FORCEPS (I.E., THE HIGH DENSITY CURRENT) WHICH RESULTED IN BURN. TO AVOID THIS TYPE SITUATION, ONLY INSULATED FORCEPS SHOULD BE USED OR COAGULATION SHOULD BE DONE THROUGH DIRECT TISSUE CONTACT WITH A HANDLE. 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 AN INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A CAESAREAN SECTION. THE ESU WAS USED WITH MONOPOLAR HANDLES (PART NUMBER 20190-045, LOT NUMBERS WO324086 AND WO340524) AND NON-ISOLATED FORCEPS. AN ERBE NESSY OMEGA RETURN ELECTRODE WAS ATTACHED TO THE PATIENT'S LEFT THIGH. THE ESU SETTINGS WERE FORCED COAG, 80 WATTS (NOTE: THE EFFECT SETTING WAS NOT REPORTED.). DURING INDIRECT COAGULATION, THE PHYSICIAN SUFFERED A MINUTE BURN ON THEIR FINGERTIP. THE NECROSIS WAS DESCRIBED AS VERY SMALL (PINHEAD-SIZED), PARTLY BLACK, AND PARTLY SUPERFICIAL. DUE TO THE INCIDENT, THE USER WAS TREATED ON AN OUTPATIENT BASIS. THERE WERE NO OTHER INJURIES TO THE PHYSICIAN AND THE PATIENT WAS UNINJURED. NOTE: ERBE (B)(4) PART NUMBER (P/N) 10128-016 IS ERBE USA P/N 10128-206.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846848 ERBOTOM ICC 350 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 350

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other