BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6562182 · Received May 11, 2017

    Report

    Report Number
    0001056128-2017-00069
    Event Type
    Malfunction
    Date Received
    May 11, 2017
    Date of Event
    April 13, 2017
    Report Date
    May 11, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NLM
    UDI-DI
    00885825016555
    PMA / PMN Number
    K062497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE SHOWS THE DEVICE WAS RETURNED WITH EVIDENCE OF CLINICAL USE. THE CANNULA SHOWED DAMAGE TO THE SHAFT WHICH WAS BROKEN OFF NEAR THE CANNULA HUB. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. DEVICES ARE REJECTED FOR ANY CANNULA SHAFT DAMAGE, THEREFORE THE DEVICE WAS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THE MOST LIKELY ROOT CAUSE IS EXCESSIVE FORCE APPLIED, CONTACT WITH A HARD OBJECT, OR SHIPPING/HANDLING DAMAGE. THE INSTRUCTIONS FOR USE (IFU) STATE: - THESE INSTRUMENTS ARE ONLY INTENDED FOR USE BY INDIVIDUALS WITH ADEQUATE TRAINING AND FAMILIARITY WITH MINIMALLY INVASIVE TECHNIQUES. - PRIOR TO USE, READ AND FOLLOW THE INSTRUCTIONS OF THIS INSERT (IFU) AS WELL AS THOSE OF THE INSTRUMENTS TO BE USED DURING THE PROCEDURE. DAMAGE TO THE INSTRUMENT CAN LEAD TO PATIENT INJURIES. ALWAYS INSPECT INSTRUMENT CAREFULLY FOR OVERALL INTEGRITY BEFORE USE. - DO NOT USE EXCESSIVE FORCE. - CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE. - 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 II WAS OPENED AND THE INSTRUMENT WAS NOT USED, RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS FOR RESTERILIZATION BY ETHYLENE OXIDE (ETO) GAS. - INSPECT THE INSTRUMENTS FOR ANY DAMAGE. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TROCAR BROKE IN HALF AT THE BASE DURING THE PROCEDURE. NOTHING FELL INTO THE PATIENT AND THE DEVICE WAS EASILY REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340825 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER SUSTAINABILITY SOLUTIONS LAKELAND NB5STF 5483775 00885825016555

    Patients

    Seq Age Sex Outcome Treatment
    1