BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300D

    MDR report key: 5239765 · Received November 20, 2015

    Report

    Report Number
    9610614-2015-00015
    Event Type
    Injury
    Date Received
    November 20, 2015
    Date of Event
    August 27, 2015
    Report Date
    November 20, 2015
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDICAL FACILITY REPORTED THAT USER ERROR CAUSED THE REPORTED ISSUE AND THEY DO NOT CONSIDER THE INCIDENT TO BE RELATED TO ERBE EQUIPMENT. NO ANOMALIES WERE FOUND UPON THE REVIEW OF THE UNIT'S DEVICE HISTORY RECORD (DHR). TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE TRAINING WAS OFFERED. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE ACCOUNT VOLUNTARILY REPORTED TO FDA IN REPORT NUMBER MW5057523 THE FOLLOWING: "THE PT HAD A HYSTEROSCOPIC REMOVAL OF POLYP AND D&C ON (B)(6) 2015. THE OPERATING HYSTEROSCOPE WAS PLACED WITH A LOOP CAUTERY. ATTEMPT WAS MADE TO GET TO THE BASE BUT BECAUSE OF ANGULATION, THE CAUTERY COULD NOT BE UTILIZED. THE HYSTEROSCOPE WAS REMOVED AND THE POLYP FORCEPS WERE USED TO REMOVE THE POLYP. A SHARP CURETTAGE WAS PERFORMED. HYSTEROSCOPE WAS AGAIN PLACED AND THE BASE WAS CAUTERIZED USING CUTTING CURRENT. IT WAS NOTED THAT THE SODIUM CHLORIDE LOSS WAS UP TO 700 ML. THE UTERINE CAVITY WAS VISUALIZED WITH NO OBVIOUS PERFORATION VISIBLE. ON (B)(6) 2015, THE PT PRESENTED TO THE ED FOR THE ABRUPT ONSET OF ABDOMINAL PAIN. THE PT WAS BROUGHT TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY FOR PERFORATION OF THE UTERUS S/P HYSTEROSCOPY AND SMALL BOWEL INJURY. THE SMALL INTESTINE WAS NOTED TO HAVE A FOCAL PERFORATION WHICH WAS THOUGHT TO BE A THERMAL INJURY, WHICH WAS CLOSED WITH SUTURES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769634 ERBE VIO 300D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO300D

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R