BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 3

    MDR report key: 19567769 · Received June 19, 2024

    Report

    Report Number
    9610614-2024-00035
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    January 22, 2024
    Report Date
    July 31, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K190823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNIT WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. 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 UNIT. IN CONCLUSION, THERE WERE NO ISSUES WITH THE ESU THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED WITH THE REPORTED EVENT AND NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICING IS BEING OFFERED TO THE INVOLVED MEDICAL PERSONNEL. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    A REQUEST HAS BEEN MADE TO THE ACCOUNT TO HAVE THE INVOLVED ESU EVALUATED BY ERBE [NOTE: NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE.]. IF THE GENERATOR IS INSPECTED/TESTED AND AN ERBE EQUIPMENT PROBLEM IS FOUND THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT, THEN A FOLLOW-UP REPORT WILL BE FILED. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED WITH THE REPORTED EVENT. THE POLYP MAY HAVE BEEN LARGE AND VERY VASCULARIZED, THE ESU SETTINGS MAY HAVE BEEN TOO LOW (I.E., NOT SUFFICIENT TO CONTROL THE BLEEDING), THE SNARE WIRE MAY HAVE BEEN DEFECTIVE, ETC. AS A RESULT, A CONCLUSIVE DETERMINATION AS TO THE CAUSE OF THE INCIDENT IN ALL LIKELIHOOD WILL NOT BE POSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH FDA'S MEDWATCH PROGRAM BY THE MEDICAL FACILITY (NUMBER: MW5154617) THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A COLONOSCOPY TO REMOVE A POLYP (I.E., A POLYPECTOMY). IT WAS STATED IN THE REPORT, "MALFUNCTION ON CAUTERIZATION MACHINE IN COLONOSCOPY PROCEDURE DURING REMOVAL OF POLYP. REQUIRED EPI INJECTION AND MULTIPLE CLIPS TO STOP BLEEDING." ADDITIONALLY, IT WAS REPORTED IN (B)(6), 2024 THAT A GROUNDING PAD AND A 13MM SNARE WERE USED IN THE PROCEDURE. THE ESU SETTINGS WERE COAG, EFFECT 1.5 AND CUT, EFFECT 3. WHEN THE PEDAL WAS DEPRESSED, THERE WAS NO CAUTERY. THEN, IT WAS DOCUMENTED THAT, "WE HAD USED THE ERBE EARLIER THAT DAY AND IT WORKED FINE WITH NO ISSUES. DURING THE CASE IN QUESTION, IT HAS A POLYP SHE WANTED TO CUT WITH A HOT SNARE. THE PATIENT WAS GROUNDED, LIGHT WAS GREEN, CORRECT ERBE SETTING WAS ACTIVE, ERBE CORD WAS PLUGGED INTO SNARE, AND THE 'NORMAL' SOUND THE ERBE MAKES WHEN ITS IN ACTION WAS HEARD, BUT AS THE POLYP WAS BEING CUT THERE WAS NO BURNING (THE NORMAL BURNING SMELL WAS ABSENT AS WELL) FROM THE ERBE AND THE CUT ENDED UP BEING A COLD CUT AND RESULTED IN THE PATIENT BLEEDING PROFUSELY. WE WERE ABLE TO QUICKLY USE EPI AND CLIPS TO CONTROL THE BLEED AND THOUGHT MAYBE THE SNARE OR CORD WAS BAD AND CHANGED BOTH OF THEM- WE ATTEMPTED TO USE THE TIP ON THE NEW SNARE AND SAME THING, THERE WAS NO BURNING WITH IT WHEN THE FOOT PEDAL WAS APPLIED. FOR THE NEXT POLYP, WE ENDED UP SWITCHING THE ERBE MACHINE OUT WITH ONE FROM ANOTHER ROOM AND THE OTHER MACHINE WORKED. EQUIPMENT/BIOMED GUY CAME TO ASSESS THE MACHINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH FDA'S MEDWATCH PROGRAM BY THE MEDICAL FACILITY (NUMBER: MW5154617) THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A COLONOSCOPY TO REMOVE A POLYP (I.E., A POLYPECTOMY). IT WAS STATED IN THE REPORT, "MALFUNCTION ON CAUTERIZATION MACHINE IN COLONOSCOPY PROCEDURE DURING REMOVAL OF POLYP. REQUIRED EPI INJECTION AND MULTIPLE CLIPS TO STOP BLEEDING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596224 ERBE VIO 3 ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 3

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other