BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 15232047 · Received August 16, 2022

    Report

    Report Number
    9610614-2022-00027
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 16, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS A PLAN TO HAVE THE ERBE EQUIPMENT CHECKED/EVALUATED AT ERBE USA. IF ANY ISSUES ARE FOUND, A FOLLOW UP REPORT WILL BE PROVIDED. NO ANOMALIES WERE FOUND IN DEVICE HISTORY RECORDS (DHRS) OF THE INVOLVED DEVICES. MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE EVENT. HOWEVER, THE PATIENT'S CONDITION APPEARS TO HAVE PLAYED A SIGNIFICANT ROLE IN THE INCIDENT. THE PATIENT IS VERY OLD, HAS A HISTORY OF ANEMIA/INDICATING BLEEDING, HAS AVMS THROUGHOUT GI TRACT (AND ESPECIALLY IN THIN-WALLED AREAS), ETC. SPECIFICALLY, UPON THE INTERVENTION WORK, THE REMAINING TISSUE OF THE SMALL BOWL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. NEVERTHELESS, AT THIS TIME, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING PLANNED AT THE ACCOUNT WITH THE INVOLVED STAFF ON 08/16/2022. 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 ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 300 D, PART NUMBER (P/N) 10140-100, SERIAL NUMBER (B)(4)) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT UPON AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND COLONOSCOPY (PATIENT HAD A HISTORY OF ANEMIA.). AN APC PROBE WAS USED IN THE PROCEDURES. ARGON PLASMA COAGULATION WAS APPLIED TO ADDRESS GASTRIC, SMALL BOWEL, AND COLONIC ARTERIOVENOUS MALFORMATIONS (AVMS). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. THE NEXT DAY, SHE WAS ADMITTED AT ANOTHER HOSPITAL ((B)(6) HOSPITAL) AND TREATED FOR A DELAYED PERFORATION. A RESECTION PROCEDURE WAS PERFORMED TO REMEDY A PERFORATION IN THE SMALL BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221781 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Hospitalization| R