BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 14371307 · Received May 12, 2022

    Report

    Report Number
    9610614-2022-00014
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    March 28, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERBE ESU AND ITS FOOTSWITCH, PER THE ACCOUNT, ARE BEING RETURNED FOR AN EVALUATION. ONCE THE EQUIPMENT IS INSPECTED/TESTED, A FOLLOW-UP MDR WILL BE PROVIDED/SENT.

    Additional Manufacturer Narrative · 0

    THE ERBE ESU AND ITS FOOTSWITCH WERE RETURNED AND EVALUATED. THE FINDINGS WERE AS FOLLOWS: ESU THE UNIT WAS/IS FUNCTIONING AS INTENDED. THE EVALUATION INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION 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 CHRONOLOGICAL DATA DID NOT SHOW THAT THE UNIT CHANGED FROM ENDO CUT Q TO DRY CUT. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE INVOLVED DEVICE (NOTE: SOME UNRELATED SERVICE WORK WAS PERFORMED ON THE ESU.) FOOTSWITCH THE ACCESSORY'S CUT (YELLOW) AND COAG (BLUE) PEDALS WERE TESTED AND FOUND TO BE FUNCTIONING PROPERLY. UNRELATED TO THE COMPLAINT, THE REMODE BUTTON DID NOT WORK. THE ACCOUNT WAS ALREADY AWARE OF THE ISSUE WITH THE REMODE AND TOLD US THAT THE REMODE BUTTON IS NOT BEING USED AS THEY DO NOT HAVE ANY SUB SETTING/PROGRAMS INSTALLED IN THE ESU. NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT, BUT NO CONCLUSION DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE EVENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICING IS BEING OFFERED TO THE CUSTOMER. 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 COLONOSCOPY/ESOPHAGOGASTRODUODENOSCOPY (EGD) TO REMOVE A POLYP. THE ESU WAS USED WITH A BOSTON SCIENTIFIC CAPTIFLEX¿SMALL OVAL FLEXIBLE SNARE (REFERENCE NUMBER (B)(4)). THE ESU SETTINGS WERE ENDOCUT Q, EFFECT 3 CUT DURATION 1, CUT INTERVAL 4 AND FORCED COAG EFFECT 2, MAXIMUM 25 WATTS (PROGRAM 10). HOWEVER, IT WAS STATED THAT WHEN PEDAL WAS DEPRESSED THE UNIT ACTIVATED IN DRY CUT MODE (BASIC PROGRAM, 0). THERE WAS A LARGE BURN AT THE POLYPECTOMY SITE; THEREFORE, HEMOCLIPS WERE APPLIED. LATER, A PERFORATION WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY, EXPLORATORY LAPAROTOMY, AND A RIGHT COLON RESECTION WITH PRIMARY ITEOSTOMY WAS PERFORMED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING A COLONOSCOPY/ESOPHAGOGASTRODUODENOSCOPY (EGD) TO REMOVE A POLYP. THE ESU WAS USED WITH A BOSTON SCIENTIFIC CAPTIFLEX¿ SMALL OVAL FLEXIBLE SNARE (REFERENCE NUMBER (B)(4)). THE ESU SETTINGS WERE ENDOCUT Q, EFFECT 3, CUT DURATION 1, CUT INTERVAL 4 AND FORCED COAG, EFFECT 2, MAXIMUM 25 WATTS (PROGRAM 10). HOWEVER, IT WAS STATED THAT WHEN THE PEDAL WAS DEPRESSED THE UNIT ACTIVATED IN DRY CUT MODE (BASIC PROGRAM, 0). THERE WAS A LARGE BURN AT THE POLYPECTOMY SITE; THEREFORE, HEMOCLIPS WERE APPLIED. LATER, A PERFORATION WAS DETECTED. A DIAGNOSTIC LAPAROSCOPY, EXPLORATORY LAPAROTOMY, AND A RIGHT COLON RESECTION WITH PRIMARY ITEOSTOMY WAS PERFORMED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311887 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention| H