BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 6075996 · Received November 3, 2016

    Report

    Report Number
    0001056128-2016-00140
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS LAKELAND
    Product Code
    NUJ
    UDI-DI
    00885825013288
    PMA / PMN Number
    K110189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. UPON VISUAL INSPECTION, THE RETURNED COMPLAINT DEVICE SHOWED SIGNS OF CLINICAL USE. THE SHAFT AND BLADES HAD DEBRIS PRESENT. INSPECTION OF THE BLADES REVEALED ABNORMAL WEAR. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THEREFORE, THE MOST LIKELY ROOT CAUSE(S) ARE: USER ATTEMPTS TO CUT STAPLES, CLIPS, OR NON-SOFT TISSUE. WEAR TO BLADES DUE TO CLINICAL USE. THE INSTRUCTIONS FOR USE (IFU) STATE: DO NOT DIRECTLY APPLY CURRENT TO STAPLES OR CLIPS. INSTRUMENTS WERE DESIGNED FOR CUTTING SOFT TISSUE. ATTEMPTING TO CUT STAPLES OR CLIPS MAY DAMAGE THE INSTRUMENT. IF CUTTING OF STAPLES OR CLIPS IS ATTEMPTED, DAMAGE TO INSTRUMENT MAY OCCUR. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 5DCS WAS DULL AND WOULD NOT CUT CORRECTLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED TO RETRIEVE ANOTHER 5DCS WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729081 NA ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R NUJ STRYKER SUSTAINABILITY SOLUTIONS LAKELAND 5DCS 4323259 00885825013288

    Patients

    Seq Age Sex Outcome Treatment
    1