BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVO SURGICAL INC.

    MDR report key: 12018426 · Received June 17, 2021

    Report

    Report Number
    3008770252-2021-00002
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 17, 2021
    Manufacturer
    NOVO SURGICAL INC.
    Product Code
    MDM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUS VOLUNTARY REPORT FROM THE FDA (MW5100995) WAS THE SECOND REPORT RECEIVED BY NOVO SURGICAL FOR AN EVENT REPORTED FOR NOVO SURGICAL ITEM CODE G4354-11. UPON RECEIVING THIS LETTER FROM THE FDA, NOVO SURGICAL CAME TO AN UNDERSTANDING THAT BOTH THE EVENTS (MW5100804 AND "MW510099"), FOR THE SAME ITEM AND LOT WERE REPORTED BY THE SAME USER FACILITY. ADDITIONAL INFORMATION WAS REQUESTED FROM THE USER FACILITY AND THE REPORTED DEVICES WERE REQUESTED TO BE RETURNED BACK FOR EVALUATION. NO PATIENT ASSOCIATED INJURIES WERE REPORTED BY THE USER FACILITY. HOWEVER, SPECIFIC INFORMATION ABOUT THE PRODUCT ASSOCIATED USAGE OR ITS MALFUNCTION, WERE NOT PROVIDED BY THE USER FACILITY. TO THIS DATE. IN ADDITION TO THIS, THE USER FACILITY HAS NOT BEEN WILLING TO RETURN THE ITEMS BACK FOR EVALUATION. 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. NOVO SURGICAL IDENTIFIED NO SIMILAR COMPLAINTS OR NON-CONFORMITIES BEING REPORTED IN ITS DEVICE HISTORY. CONTINUED INVESTIGATION MEASURES ARE CURRENTLY BEING TAKEN FOR IDENTIFYING ANY PRODUCT ASSOCIATED DEFECTS. 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 MW5100995) NOTIFYING IT OF A MDR SUBMITTED BY THE A USER/FACILITY WITH REGARDS TO A CRILEWOOD NEEDLE HOLDER, TUNGSTEN CARBIDE, SERRATED JAWS,(ITEM NO. G4354-11) SUPPLIED BY NOVO SURGICAL. THE FDA CORRESPONDENCE DATED MAY 6, 2021 WAS DELIVERED VIA POSTAL MAIL AND RECEIVED BY NOVO SURGICAL ON MAY 18, 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 APRIL 22, 2021. THE EVENT INDICATES A PRODUCT MALFUNCTION WHERE THE TIP OF THE NEEDLE DRIVER BROKE DURING SURGERY. THE BROKEN TIP WAS RECOVERED AND NO PATIENT ASSOCIATED INJURY WERE REPORTED. THE SUS VOLUNTARY EVENT REPORT FROM THE FDA (REPORT MW5100995) 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
    918461 NOVO SURGICAL INC. CRILE-WOOD NEEDLE HOLDER TUNGSTEN CARBIDE, SERRATED JAWS, 6" MDM NOVO SURGICAL INC. G4354-11 01/19PD

    Patients

    Seq Age Sex Outcome Treatment
    1