BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN MONOPOLAR CORD

    MDR report key: 7803602 · Received August 21, 2018

    Report

    Report Number
    3000719969-2018-00008
    Event Type
    Malfunction
    Date Received
    August 21, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 19, 2023
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785107665
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CORD WAS SOLD TO THE CUSTOMER ON (B)(6) 2015 ON ORDER #(B)(4). THEREFORE, THE CORD HAS BEEN IN USE FOR APPROXIMATELY 3 YEARS. PER THE INSTRUMENT IFU, EACH OLSEN REUSABLE DEVICE IS DESIGNED TO WITHSTAND 20 STERILIZATION CYCLES WHEN PROPERLY CARED FOR AND STERILIZED PER THE INSTRUCTIONS FOR USE. IT WAS ALSO NOTED THAT THE BURN OCCURRED AT THE FEMALE END OF THE CORD, CAUSING IT TO SEVER IN HALF AT THAT SPOT. CUSTOMER DID NOT RETURN THE OLSEN COMPLAINT FORM TO AID IN THE INVESTIGATION. CORD WAS SENT TO OLSEN (B)(6) 2018 FOR EVALUATION. THEIR FINDINGS ARE AS FOLLOWS: REVIEWED THE MFG INFORMATION OF THE PRODUCT AND NOTED IT WAS COMPLETED MANUFACTURING IN (B)(6) 2014. THEREFORE, THIS WILL MAKE THE DEVICE OVER 3.5 YEARS OLD. IN ADDITION, THERE ARE WEAR AND TEAR MARKS (SCRATCHES, DENTS, AND DISCOLORATION) ON THE CORD AND THE ADAPTER PLUG END ITSELF. THEREFORE, IT CAN BE SAID THAT THE DEVICE WENT THROUGH A LOT OF USAGE AND REPROCESSING. TRUE ROOT CAUSE CANNOT BE DETERMINED AS DEVICE USAGE, SPECIFICATIONS, AND OPERATING PARAMETERS CANNOT BE DETERMINED. BASED ON THE DEVICE, IT IS BELIEVED THAT IS HAS BEEN USED OVER ITS RECOMMENDED LIFE. IT IS RECOMMENDED THAT CUSTOMER FOLLOW CLEANING, STERILIZATION, USAGE, AND STORAGE RECOMMENDATION PER THE IFU. BASED ON THE ABOVE INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AND THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL INFORMATION PERTINENT TO THE INVESTIGATION, A SUBSEQUENT FOLLOW UP REPORT WILL BE SUBMITTED. THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST.

    Description of Event or Problem · 1

    OLSEN MONOPOLAR CORD CAUGHT ON FIRE. NO PATIENT OR STAFF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641369 OLSEN MONOPOLAR CORD MONOPOLAR CORD GEI OLSEN MEDICAL LLC 50-2111 036060 00841785107665

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown