BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT

    MDR report key: 3122563 · Received May 17, 2013

    Report

    Report Number
    9610773-2013-00035
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 23, 2013
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT AND WAS INFORMED THAT THE PROCEDURE WAS A DIAGNOSTIC COLONOSCOPY. THE PT WAS SEDATED WITH PROPOFOL. DURING THE EXAM, A 10 MM POLYP WAS NOTED IN THE CECUM. THE USER UTILIZED THE SUBJECT DEVICE VIA THE YELLOW FOOT PEDAL WITH A COOK SOFT ACUSNARE TO CAUTERIZE THE POLYP. IT WAS REPORTED THAT THERE WERE SOME REMNANTS OF THE POLYP LEFT. HENCE THE USER ACTIVATED THE YELLOW PEDAL USED WITH THE SUBJECT DEVICE AGAIN TO CAUTERIZE THE EDGE OF THE POLYP SITE AND THE PT REPORTEDLY JOLTED. THERE WAS NO REPORT OF PT INJURY. THE SETTINGS ON THE SUBJECT DEVICE WERE MONOPOLAR PULSECUT SLOW 120. THE PT WAS SENT HOME THE SAME DAY. THE FOLLOWING DAY THE PT REPORTEDLY COMPLAINED OF ABDOMINAL PAIN AND FEVER, AND WAS ADMITTED TO THE HOSPITAL. FURTHER EXAMINATION OF THE PT REVEALED THAT THERE WAS NO EVIDENCE OF BOWEL PERFORATION OR OTHER INJURIES. THE PT WAS DISCHARGED 24 HOURS LATER AND IS REPORTEDLY DORING FINE. THE SUBJECT DEVICE WAS TESTED BY THE USER FACILITY'S BIOMED DEPARTMENT AND IT WAS REPORTED TO BE WORKING PROPERLY. IN ADDITION, THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE DEVICE PASSED ALL THE ELECTRICAL SAFETY TESTS. IN ADDITION, THE USER FACILITY'S VALLEYLAB SPLIT PT PAD WAS TESTED WITH THE SUBJECT DEVICE AND IT WAS WORKING PROPERLY. THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE "THE PT JOLTED AS IF BEING SHOCKED." THERE WAS REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218821 OLYMPUS ELECTROSURGICAL UNIT ELECTROSURGICAL UNIT KNS OLYMPUS WINTER & IBE GMBH ESG-100 (WB991046) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other COOK SOFT ACUSNARE: MODEL G22632, LOT # UNK| OLYMPUS CF-HQ190L: LOT # UNK| VALLEYLAB SPLIT PAD: LOT # 251069X