BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 9882146 · Received March 26, 2020

    Report

    Report Number
    9610614-2020-00008
    Event Type
    Injury
    Date Received
    March 26, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 26, 2020
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K060484
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU AND FOOTSWITCH WERE THOROUGHLY INSPECTED/TESTED. THE FINDINGS WERE 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 FUNCTIONING PROPERLY. A REVIEW OF THE UNIT'S CHRONOLOGICAL EVENT LOGS REVEALED THAT THE LAST PROGRAM USED/SELECTED WAS 0- BASIC PROGRAM. ON THE DATE OF THE REPORTED INCIDENT, THE ESU WAS ACTIVATED AT WHAT APPEARED TO BE 4 DIFFERENT EVENTS OR PROCEDURES. THE ACTIVATIONS ALL COINCIDED WITH THE GENERATOR'S PROGRAMMED SETTINGS (I.E., FORCED COAG MODE, EFFECT 2, 20 WATTS AND ENDOCUT Q MODE, EFFECT 3). HOWEVER, THE SWIFT COAG MODE, EFFECT 4, 180 WATTS WAS ACTIVATED TWICE AT 2:59 PM. THE ACTIVATIONS IN THE SWIFT COAG MODE DO NOT COINCIDE WITH ANY PRESET PROGRAMS AND WOULD HAVE HAD TO BE MANUALLY SELECTED. AT NO TIME DURING TESTING DID THE UNIT CHANGE SETTINGS FROM THE PRESELECTED SETTINGS. FINALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED ESU. FOOTSWITCH THE ACCESSORY WAS FOUND TO BE FUNCTIONING PROPERLY. NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WILL BE OFFERED TO THE ACCOUNT. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS SENT BY THE RISK MANAGER OF THE MEDICAL FACILITY TO ERBE INDICATING THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR). THE REPORT STATED: "DURING COLONOSCOPY A 5 MM POLYP IN TRANSVERSE COLON WAS REMOVED WITH A HOT SNARE, RESECTED AND RETRIEVED. THE ERBE MACHINE PROGRAMMED SETTING OF 2 EFFECT AND 20 WATTS SELECTED AT REQUEST OF MD. WHEN FIRING, MD PRESSED CORRECT PEDAL AND MACHINE FIRED AT 4 EFFECT AND 150 WATTS. MORE TISSUE THAN ANTICIPATED WAS AFFECTED A DEEPER CUT WAS MADE. PER THE SURGEON, THE MUCOSA SURROUNDING THE POLYP HAD EXCESSIVE BURN MARKINGS. A HEMOSTATIC CLIP WAS PLACED TO PULL THE TISSUE TOGETHER WHERE THE DEEPER CUT OCCURRED. AN X-RAY WAS NEGATIVE FOR ABNORMAL FINDINGS. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION. WHEN EVALUATING THE ERBE MACHINE THE SETTINGS COULD NOT BE RECREATED. THE MACHINE WILL NOT ALLOW TECH/RN TO TAKE THE WATT SETTING ABOVE 120. MULTIPLE PREPROGRAMMED SETTINGS WERE INVESTIGATED AND NONE OF THEM WOULD ALLOW THE SETTING TO GO THAT HIGH. MACHINE REMOVED FROM PROCEDURE ROOM AND BIOMED HAS EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345925 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention