BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOLAR HIGH FREQUENCY CORD

    MDR report key: 16993285 · Received May 24, 2023

    Report

    Report Number
    9610617-2023-00101
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 24, 2023
    Report Date
    May 24, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GEI
    UDI-DI
    04048551388778
    PMA / PMN Number
    K171717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION/INVESTIGATION OF THE PRODUCT: CONNECTOR IS DISCOLORED AND WORN FROM WEAR AND TEAR. IFU 97000149 IFU V2.0(10-2017) BIPOLAR HF CABLE WARNS "INSTRUMENTS AND ALL OF THE ACCESSORIES USED IN COMBINATION WITH THEM MUST BE CHECKED IMMEDIATELY BEFORE AND AFTER EVERY USE TO ENSURE THAT THEY ARE COMPLETE, FREE FROM DAMAGE AND TO MAKE CERTAIN THAT THE PLUG CONNECTION MAINTAINS GOOD CONTACT. POOR OR INSUFFICIENT CONTACT OR DAMAGE TO THE CABLE INSULATION AND PLUGS MAY LEAD TO VOLTAGE FLASHOVERS. THIS COMPLAINT INVOLVES A TOTAL OF 6 ITEMS (972685, 972686, 972687, 972688, 972689, 972690)OF WHICH 972687 AND 972688 ARE PROBABLY THE CAUSE OF THE REPORTED ISSUE. THOSE TWO COMPLAINTS WILL BE REPORTED TO THE LOCAL COMPETENT AUTHORITY MENTIONING THE CAUSAL COMPONENTS WITHIN THE REPORT AS INVOLVED. THERE WILL BE NO SEPARATE REPORT FOR 972685,972686, 972689,AND 972690. THE MALFUNCTION IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT (UH801) BIPOLAR HIGH FREQUENCY CORD.ACCORDING TO THE INFORMATION RECEIVED, THE GENERATOR WAS NOT RESPONDING. A NEW RESTROSCOPE SET WAS OPENED AND THE CORD PLUGGED IN AND THE ENGERY SETTING FOR SALINE TUR WAS CHOSEN. WHEN THE SURGEON TESTED THE INSTRUMENT A LOUD POP WAS HEARD AND HE DROPPED THE INSTRUMENT INTO THE CYSTO DRAIN BAG. THE SURGEON CHANGED GLOVES AND HIS SKIN WAS FOUND TO BE INTACT. THE CORD WAS FOUND TO HAVE A BURN MARK.THERE WAS NOT HARM TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508780 BIPOLAR HIGH FREQUENCY CORD BIPOLAR HIGH FREQUENCY CORD FOR KARL STORZ GENERATOR UH400U GEI KARL STORZ SE & CO. KG UH801 SO02-04342 04048551388778

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male 27040EB.UH801.27040EB.UH400UUF902-T