BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE ICC 200 E/A

    MDR report key: 7207150 · Received January 19, 2018

    Report

    Report Number
    9610614-2017-00035
    Event Type
    Injury
    Date Received
    January 19, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 19, 2018
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933157
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ESU WAS RETURNED AND THOROUGHLY EVALUATED. THE UNIT'S OUTPUTS WERE FOUND TO WITHIN SPECIFICATIONS. HOWEVER, THE GENERATOR'S FINGERSWITCH FEATURE WAS NOT WORKING (NOTE: THERE IS NO INDICATION THAT THE NONCONFORMING FINGERSWITCH FUNCTION HAD ANYTHING TO DO WITH THE PERFORATION BECAUSE THE UNIT DID ACTIVATE AND PRODUCED OUTPUTS WITHIN SPECIFICATIONS. IT APPEARS THAT THE ACTIVATION OCCURRED WITH A FOOTSWITCH AND THE FOOTSWITCH FEATURE WAS/IS WORKING PROPERLY.). INSPECTION/TESTING REVEALED A THERMAL DAMAGED COMPONENT [I.E., RESISTOR (R1)] ON THE UNIT'S MONO OUTPUT PRINTED CIRCUIT BOARD (PCB). NO DETERMINATION WAS MADE AS TO WHAT CAUSED THE DAMAGE TO THE PCB. NEVERTHELESS, THE BOARD WAS REPLACED AND THE FUNCTIONALITY OF THE FINGERSWITCH FEATURE WAS RESTORED. AFTER THE REPAIR, A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT TO CONFIRM THAT ALL FEATURES ARE FUNCTIONING PROPERLY. THE GENERATOR MEETS SPECIFICATIONS. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). IN CONCLUSION, NO EQUIPMENT RELATED ISSUE WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT AND 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 WAS PERFORMED WITH THE INVOLVED MEDICAL STAFF ON (B)(6) 2018. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS USED IN COLONOSCOPY IN WHICH A LARGE POLYP WAS ENCOUNTERED. THE POLYP WAS RAISED WITH NORMAL SALINE PRIOR TO REMOVAL. THE ESU WAS SET TO THE STANDARD ENDOCUT SETTING. THE POLYP REMOVED USING HOT SNARE. A "POP" WAS HEARD WHEN THE GENERATOR WAS ACTIVATED. A PERFORATION OCCURRED AND TWO (2) CLIPS WERE USED TO ADDRESS THE PERFORATION. NO SURGICAL INTERVENTION WAS NECESSARY BUT THE PATIENT WAS ADMITTED TO THE HOSPITAL. NOTE: THE HOSPITAL'S BIOMEDICAL TECHNICIAN CHECKED THE UNIT AND FOUND THE OUTPUTS TO BE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48732 ERBE ICC 200 E/A ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 200 E/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization