BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3812620 · Received May 15, 2014

    Report

    Report Number
    0001056128-2014-00056
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLQ
    PMA / PMN Number
    K043315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT AN INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE AN INVESTIGATION IS COMPLETED A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THE PRESENCE OF FOREIGN MATERIAL. HOWEVER, RESULTS FROM THE MATERIAL ANALYSIS WERE INCONCLUSIVE DUE TO THE SAMPLE SIZE OF THE DEBRIS BEING INSUFFICIENT. THE DEVICE HAD EVIDENCE OF CLINICAL USE. THEREFORE, IT IS LIKELY THE FOREIGN MATERIAL CAME IN CONTACT WITH THE DEVICE DURING USE. THE INSTRUCTIONS FOR USE (IFU) STATES: "INSPECT THE INSTRUMENT AND PACKAGE BEFORE OPENING. THE CONTENTS OF THE PACKAGE ARE STERILE IF THE PACKAGING HAS NOT BEEN COMPROMISED. IF THE PACKAGE IS DAMAGED OR IF IT WAS OPENED AND THE INSTRUMENT WAS NOT USED, RETURN THE INSTRUMENT AND PACKAGE TO STRYKER SUSTAINABILITY SOLUTIONS." THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING AN ULTRASONIC SCALPEL, "WHEN THE DEVICE WAS PUT IN THE PATIENT, JUST BEHIND THE TEFLON TIP, THERE'S RESIDUE." NO ADVERSE EVENTS WERE REPORTED BY THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING AN ULTRASONIC SCALPEL, "WHEN THE DEVICE WAS PUT IN THE PATIENT, JUST BEHIND THE TEFLON TIP, THERE'S RESIDUE." NO ADVERSE EVENTS WERE REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291697 NA SCALPEL, ULTRASONIC, REPROCESSED NLQ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ACE36E 2873616

    Patients

    Seq Age Sex Outcome Treatment
    1