BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO SURGICAL INC.

    MDR report key: 12155487 · Received July 12, 2021

    Report

    Report Number
    3008770252-2021-00003
    Event Type
    Malfunction
    Date Received
    July 12, 2021
    Date of Event
    May 5, 2021
    Report Date
    July 12, 2021
    Manufacturer
    NOVO SURGICAL INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUS VOLUNTARY REPORT FROM THE FDA (MW5101314) WAS THE FIRST REPORT RECEIVED BY NOVO SURGICAL FOR AN EVENT REPORTED FOR NOVO SURGICAL ITEM CODE G4325-11. NOVO SURGICAL STARTED ITS PRELIMINARY INVESTIGATION BY REVIEWING THE DEVICE HISTORY RECORDS OF THE ITEM FOR ANY SIMILAR COMPLAINTS OR NON-CONFORMITIES. NO SIMILAR ISSUES OR NON-CONFORMITIES WERE NOTED FOR THIS PARTICULAR ITEM. NO PATIENT ASSOCIATED INJURIES WERE REPORTED BY THE USER FACILITY. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY AND THE REPORTED DEVICES WERE REQUESTED TO BE RETURNED BACK FOR EVALUATION. HOWEVER, TO THIS DATE, THE USER FACILITY HAS NOT BEEN WILLING TO RETURN THE ITEMS BACK FOR EVALUATION. IN ADDITION TO THIS, SPECIFIC INFORMATION ABOUT THE PRODUCT ASSOCIATED USAGE OR ITS MALFUNCTION, WERE NOT PROVIDED BY THE USER FACILITY. AS A RESULT OF THIS, IT IS DIFFICULT TO DETERMINE IF THE EVENT OCCURED DUE TO PRODUCT MALFUNCTION OR DUE TO ANY USER RELATED ERRORS. AS A PART OF NOVO SURGICAL'S INVESTIGATION, A BRAND NEW ITEM FROM STOCK WAS SENT OUT TO AN INDEPENDENT LABORATORY FOR SPECIFICATION ANALYSIS. CONTINUED EFFORTS OF OBTAINING EVENT ASSOCIATED INFORMATION ARE ALSO BEING TAKEN. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOVO SURGICAL INC. RECEIVED A SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5101314) NOTIFYING IT OF A MDR SUBMITTED BY THE A USER/FACILITY WITH REGARDS TO A MAYO-HEGAR NEEDLE HOLDER, TUNGSTEN CARBIDE, SERRATED JAWS,(ITEM NO. G4325-11) SUPPLIED BY NOVO SURGICAL. THE FDA CORRESPONDENCE DATED MAY 24, 2021 WAS DELIVERED VIA POSTAL MAIL AND RECEIVED BY NOVO SURGICAL ON JUNE 12, 2021. THIS WAS THE FIRST NOTIFICATION TO NOVO SURGICAL OF THIS COMPLAINT. THE SUS VOLUNTARY EVENT REPORT INDICATED THAT AN EVENT THAT HAPPENED ON (B)(6) 2021 WAS REPORTED TO THE FDA, BY THE USER FACILITY ON MAY 10, 2021. THE EVENT INDICATES A PRODUCT MALFUNCTION WHERE THE TIP OF THE NEEDLE DRIVER BROKE OFF WHILE CLAMPING ONTO THE NEEDLE. NO PATIENT ASSOCIATED INJURIES/COMPLICATIONS OR A NEED OF SURGICAL INVENTION WAS REPORTED BY THE USER FACILITY. THE SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5101314) WAS THE FIRST NOTIFICATION RECEIVED BY NOVO SURGICAL OF THE EVENT. NO NOTIFICATION FROM THE USER FACILITY WAS RECEIVED BY NOVO SURGICAL PRIOR TO THE SUS VOLUNTARY REPORT FROM THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052884 NOVO SURGICAL INC. MAYO-HEGAR NEEDLE HOLDER, TUNGSTEN CARBIDE, SERRATED JAWS, 8" (20.3 CM) MDM NOVO SURGICAL INC. G4325-11 V03/19PD

    Patients

    Seq Age Sex Outcome Treatment
    1