BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPROSCOPIC EXTENDED APPLICATOR

    MDR report key: 3243262 · Received July 23, 2013

    Report

    Report Number
    0002530131-2013-00006
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SALES REP THAT THE BLACK OUTER PLASTIC OF THE LEA APPLICATOR SHEARED OFF IN A PATIENT DURING A PROCEDURE. THE PROCEDURE WAS DELAYED TO REMOVE THE PIECES WHICH WERE ALL WERE RETRIEVED. UPON RECEIPT OF THE DEVICE, A VISUAL INSPECTION CONFIRMED THAT THE BLACK PLASTIC COVERING OF THE LEA HAD A SMALL SLIT AT THE TOP EDGE OF THE BLACK PLASTIC ENCLOSURE. THIS MAY HAVE OCCURRED AS A RESULT OF SHARP SURGICAL INSTRUMENTS COMING IN CONTACT WITH THE DEVICE DURING THE PROCEDURE AS IT IS UNLIKELY THAT THIS COULD HAVE WENT UNNOTICED DURING THE MANUFACTURING AND PACKAGING PROCESS. THE TIP OF THE LEA WAS RETURNED BENT AND WELL BELOW THE TOP EDGE OF THE PLASTIC COVERING. IT COULD NOT BE DETERMINED WHETHER OR NOT THIS CONTRIBUTED TO THE SHEARING OFF OR IF IT OCCURRED AS A THE RESULT OF THE SHEARING OFF. AS A RESULT OF THESE FINDINGS,THE ROOT CAUSE FOR THIS FAILURE MODE COULD NOT BE CONFIRMED AND THUS IT CANNOT BE CONCLUDED WHETHER OR NOT THERE IS A PRODUCT PROBLEM ASSOCIATED WITH THIS EVENT. CORRECTIVE ACTION WAS NOT TAKEN SINCE IT CANNOT BE CONFIRMED WHETHER THE FAILURE HAPPENED AS A RESULT OF A MANUFACTURING ERROR OR USER MISHANDLING OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343928 LAPROSCOPIC EXTENDED APPLICATOR LEA LMF STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other