BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN

    MDR report key: 9648540 · Received January 30, 2020

    Report

    Report Number
    3000719969-2020-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 8, 2020
    Report Date
    January 30, 2020
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785107665
    PMA / PMN Number
    K111262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE RETURNED INSTRUMENT, IT WAS CONFIRMED THAT THE CORD HAD BURNT INTO TWO PIECES NEAR THE INSTRUMENT CONNECTION SIDE OF THE INSTRUMENT. BASED ON THE LOT NUMBER ON THE CORD, IT CAN BE DETERMINED THAT THE CORD WAS PURCHASED IN (B)(6) 2017. THE IFU STATES THAT EACH OLSEN REUSABLE DEVICE IS DESIGNED TO WITHSTAND 20 STERILIZATION CYCLES WHEN PROPERLY CARED FOR AND STERILIZED PER THE INSTRUCTIONS FOR USE. THE RETURNED CORED HAD BEEN IN USE FOR APPROXIMATELY 2.5 YEARS AND HAD SIGNIFICANT SIGNS OF WEAR AND TEAR. THE FIRE THAT OCCURRED IS THE RESULT OF EXTENSIVE BENDING WHERE THE CORD CONNECTS TO THE BIPOLAR FORCEPS. WITH SIGNIFICANT BENDING IN THE SAME SPOT THE INTERNAL WIRES OF THE CORD WITH BEGIN TO WEAR. THERE HAS BEEN A TOTAL OF 3,711 SOLD SINCE 2013 WITH 4 COMPLAINTS RECORDED FOR SIMILAR OCCURRENCES (0.1%) IN ALL OTHER CASES, THE CORD HAS BEEN USED FOR A SIGNIFICANT AMOUNT OF TIME. BASED ON THIS INFORMATION, THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY OTHE PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE MONOPOLAR CORD QUIT WORKING DURING THE CASE. THE TECH IN THE ROOM ADJUSTED THE CORD CONNECTION AND IT STARTED WORKING AGAIN BUT A SMALL FLAME ROSE FROM THE CORD NEAR THE MONOPOLAR SCISSOR CONNECTION. IT WENT OUT IMMEDIATELY WITH NO HARM TO THE PATIENT OR USER. THE EQUIPMENT WAS REMOVED FROM THE FILED AND NEW EQUIPMENT WAS USED TO COMPLETE THE CASE WITH NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113783 OLSEN MONOPOLAR CORD GEI OLSEN MEDICAL LLC 50-2111 103799 00841785107665

    Patients

    Seq Age Sex Outcome Treatment
    1