BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO SURGICAL INC.

    MDR report key: 12229619 · Received July 27, 2021

    Report

    Report Number
    3008770252-2021-00006
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    May 19, 2021
    Report Date
    July 26, 2021
    Manufacturer
    NOVO SURGICAL INC.
    Product Code
    GEN
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NOVO SURGICAL INC. RECEIVED A SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5101715) NOTIFYING IT OF A MDR SUBMITTED BY A USER FACILITY WITH REGARDS TO A ZENITH ROCHESTER OCHSNER FORCEPS, 1X2 TEETH, STRAIGHT, (ITEM NO. G92723-31) SUPPLIED BY NOVO SURGICAL. THIS IS THE THIRD SUS VOLUNTARY REPORT RECEIVED FOR THIS DEVICE WITH SAME LOT FROM THE SAME USER FACILITY. IT IS UNCLEAR WHETHER THE USER FACILITY SUBMITTED DUPLICATE REPORTS FOR THE SAME PRODUCT CONCERN. NO CLARIFICATION OR ADDITIONAL INFORMATION WAS PROVIDED BY THE USER FACILITY UPON NOVO SURGICAL'S REQUEST FOR INVESTIGATION QUESTIONS. 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 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 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. WITH LITTLE TO NO INFORMATION PROVIDED BY THE USER FACILITY, NOVO SURGICAL PERFORMED ITS INTERNAL INVESTIGATION BY SENDING OUT A PIECE OF THE CONCERNED DEVICE WITH THE SAME REPORTED LOT TO AN INDEPENDENT LABORATORY FOR HARDNESS TESTING AT THE SPECIFIC POINT OF BREAKAGE. THE HARDNESS SURVEY WAS CONDUCTED AND COMPARED AGAINST THE ASTM E384-17 STANDARD WITH NO REPORTED NON-CONFORMITIES OR ISSUES WITH THE TESTED DEVICE. WITH NO MANUFACTURING DEFECTS WITH THE ITEM, NOVO SURGICAL SUSPECTS THE BREAKAGE TO BE DEEMED TO HAVE OCCURRED DUE TO A USER RELATED ERROR. AT THIS TIME, NOVO SURGICAL IDENTIFIES NO CORRECTIVE AND/OR PREVENTIVE ACTIONS TO BE TAKEN. IF ADDITIONAL INFORMATION AFFECTIVE THE INVESTIGATION, IS RECEIVED FROM THE USER FACILITY, OR IF THE AFFECTED DEVICE IS RETURNED FOR EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NOVO SURGICAL INC. RECEIVED A SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5101715) NOTIFYING IT OF A MDR SUBMITTED BY THE A USER/FACILITY WITH REGARDS TO A ZENITH ROCHESTER OCHSNER FORCEPS, 1X2 TEETH, STRAIGHT, (ITEM NO. G92723-31) SUPPLIED BY NOVO SURGICAL. THE FDA CORRESPONDENCE WAS DELIVERED VIA POSTAL MAIL AND RECEIVED BY NOVO SURGICAL ON JUNE 26, 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 JUNE 02, 2021. THE EVENT INDICATES A PRODUCT MALFUNCTION WHERE THE TIP OF TWO NOVO SURGICAL KOCHERS WERE FOUND TO BE BROKEN DURING A SURGICAL PROCEDURE. THE SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5101715) 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
    1123365 NOVO SURGICAL INC. ZENITH ROCHESTER-OCHSNER FORCEPS, 1X2 TEETH, STRAIGHT, 8"" (20.3 CM) GEN NOVO SURGICAL INC. G92723-31

    Patients

    Seq Age Sex Outcome Treatment
    1