BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGICAL SUCKER/SUMP SET

    MDR report key: 2092897 · Received April 11, 2011

    Report

    Report Number
    1625519-2011-00001
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Report Date
    February 10, 2011
    Manufacturer
    NOVOSCI CORP.
    Product Code
    DTS
    PMA / PMN Number
    K801400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT INFO OF THE SUBJECT DEVICE WAS NOT PROVIDED TO NOVOSCI CORP. THE SUBJECT DEVICE WAS SENT TO NOVOSCI FOR EVAL IN (B)(4) 2011. DURING THE INVESTIGATION OF THE DEVICE, IT WAS NOTED THAT THE TIP BOND WAS INTACT AND MET THE PRODUCT SPEC. THE FAILURE WAS THE TIP/SUCKER INTERFACE WHICH IS A NATURAL FLEXING POINT FOR THE DEVICE. BASED ON THE RESULTS OF THE INVESTIGATION, THE FAILURE APPEARS TO BE THE RESULT OF TOO MUCH FORCE BEING APPLIED TO THE TIP OF THE SUCKER. BASED ON THE INITIAL INFO RECEIVED BY NOVOSCI CORP ON (B)(6) 2011, AN INITIAL DETERMINATION OF THIS EVENT WAS DETERMINED NOT TO REQUIRE A MEDIAL DEVICE REPORT. HOWEVER, BASED ON ADD'L INFO RECEIVED BY THE DISTRIBUTOR, THE INFO WAS REASSESSED AND IT WAS DETERMINED THAT AN MDR WAS REQUIRED TO BE SUBMITTED TO FDA. THE DIRECTIONS FOR USE (B)(4) FOR THE SURGICAL SUCKER/SUMP SET INCLUDES A PRECAUTION STATEMENT THAT CARE SHOULD BE EXERCISED WHEN APPLYING FORCE TO ANY SUCKER OR SUMP SET SINCE EXCESSIVE BENDING OF THE TUBE OR THE TIP COULD CAUSE BREAKAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN INCIDENT WAS REPORTED TO NOVOSCI CORP BY THE DISTRIBUTOR. DURING AN OPEN HEART PROCEDURE, THE TIP OF THE HEX GROOVED SUCKER BROKE AND THE TIP FELL INTO THE PT'S OPEN CHEST CAVITY. THE SURGICAL TEAM WAS ABLE TO COMPLETELY RETRIEVE THE TIP DURING THE PROCEDURE. POST-OPERATION, THE SITE STATED THAT THE PT IS FINE AND THERE WERE NO CLINICAL SEQUELAE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SUCKER/SUMP SET SUCKER, CARDIOPULMONARY RETURN DTS NOVOSCI CORP. 201135-000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention