BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 9843011 · Received March 17, 2020

    Report

    Report Number
    3000719969-2020-00002
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    January 23, 2020
    Report Date
    May 22, 2020
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    UDI-DI
    00841785113369
    PMA / PMN Number
    K130669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER ON THE PICTURE PROVIDED WAS 044839- CORRECTED IN THE FORM. THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE USER FACILITY. BASED ON THE LOT NUMBER IN THE PICTURE, THIS PARTICULAR DEVICE WAS PURCHASED FROM SYMMETRY SURGICAL IN (B)(6) 2016. THE CORD APPEARED TO HAVE SIGNIFICANT SIGNS OF USE AS THE LOT NUMBER MARKING IS BEGINNING TO COME OFF. PER THE DATE OF PURCHASE THIS CORD HAS BEEN IN USE FOR APPROXIMATELY 3.5 YEARS. PER THE PRODUCT IFU, THIS DEVICE IS WARRANTED FOR 20 STERILIZATION CYCLES. IT CAN BE DETERMINED THAT THE DAMAGE OCCURRED DUE TO EXTENSIVE USE OVER 3 YEARS. THE EXTENSIVE BENDING IN THE CORD AT THE WORKING END CAUSES THE INTERNAL WIRING TO WEAR CAUSING A SHORT. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR NEED FOR CORRECTIVE ACTIONS, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF ALL LOTS SINCE SEPTEMBER 2016 WITH (B)(4) TOTAL COMPLAINTS RECORDED FOR SIMILAR OCCURRENCES. BOTH OF THE PREVIOUS COMPLAINTS HAD PRODUCT THAT HAD BEEN IN USE FOR OVER 4 YEARS. THE CUSTOMER REPORTED TWO LOT NUMBER: 044639 AND 044689 THEY COULD NOT CONFIRM WHICH ONE WAS INVOLVED. THE PRODUCT IS BEING RETURNED TO SYMMETRY FOR FURTHER EVALUATION. UPON RECEIVING AND EVALUATING THE RETURNED PRODUCT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING A SCHEDULED PROCEDURE, THE PHYSICIAN ATTACHED THE CORD TO A LAPAROSCOPIC INSTRUMENT, PREPARING FOR USE. THE SURGICAL TEAM SAW SMOKE, SPARKS, AND A SMALL FLAME BETWEEN THE CORD AND THE CORD ATTACHMENT ON THE INSTRUMENT. THEY IMMEDIATELY REMOVED THE CORD FROM THE ATTACHMENT, SURGICAL FIELD AND POWER. THE INCIDENT DID NOT AFFECT THE PATIENT, SURGICAL DRAPES, OR THE SURGICAL TEAM. THE CORD WAS REPLACED WITH A NEW CORD AND THE TEAM PRECEDED WITH THE PROCEDURE WITH NO FURTHER IMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309489 CONMED MONOPOLAR CORD GEI OLSEN MEDICAL LLC 044839 00841785113369

    Patients

    Seq Age Sex Outcome Treatment
    1