BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6522 LAP SPG 18X18 STR P-WX200

    MDR report key: 4760139 · Received May 8, 2015

    Report

    Report Number
    1018120-2015-00006
    Event Type
    Injury
    Date Received
    May 8, 2015
    Date of Event
    December 11, 2014
    Report Date
    April 17, 2015
    Manufacturer
    COVIDIEN
    Product Code
    EFQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR REVIEW BY THE CUSTOMER; HOWEVER, THREE PHOTOS OF THE REPORTED CONDITION WERE SUBMITTED WITH THE COMPLAINT. THE THREE X-RAY PHOTOS WERE EVALUATED FOR THE REPORTED CONDITION. ONE X-RAY PHOTO APPEARED TO SHOW AN X-RAY DETECTABLE HANDLE. THE OTHER PHOTOS POTENTIALLY SHOWED THE SPONGE INSIDE THE BODY. AS PART OF THE MANUFACTURING PROCESS, A DEVICE HISTORY RECORD (DHR) IS GENERATED FOR LOT 140000620262X WHICH CONFIRMS THAT THE LOT MET ALL ACCEPTABLE CRITERIA PRIOR TO RELEASE. BECAUSE A PHYSICAL SAMPLE WAS NOT RETURNED FOR EVALUATION OF THE DETECTABLE PART OF THE SPONGE; THE BLUE X-RAY STRIP WHICH IS 3.5 INCHES BY 5/16 INCH COULD NOT BE PERFORMED ON THE X-RAY DETECTABLE HANDLE. THE POTENTIAL ROOT CAUSE MAY HAVE BEEN A VARIATION WITHIN THE EQUIPMENT WHICH MAY HAVE REDUCED THE READABILITY OF THE ELEMENT. THERE IS NOT A COMPLAINT TREND THAT EXISTS AND A ROOT CAUSE FOR THE REPORTED CONDITION CANNOT BE SPECIFICALLY IDENTIFIED. PRODUCT CODE 6522 LOT 140000620262X WAS MANUFACTURED WITH A LAP SPONGE THAT IS PROVIDED BY A (B)(4) FOR MEDICAL PRODUCTS. THE LOT #14004A WAS RECEIVED AT COVIDIEN FOR INCOMING RAW MATERIAL INSPECTION. THE LOT 14004A WAS SUBSEQUENTLY RELEASED TO PRODUCTION PER THE CERTIFICATE OF ANALYSIS FROM THE (B)(4). AS A PRECAUTION A VENDOR QUALITY ALERT WILL BE ISSUED TO THE VENDOR NOTIFYING THEM OF THE REPORTED CONDITION. THIS ISSUE WILL BE REVIEWED DURING THE MONTHLY REPORT OUT FOR THE FACTORY. NO CHANGES TO THE QUALITY CONTROL SAMPLING PLANS ARE DEEMED NECESSARY. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. NO FORMAL CORRECTIVE ACTION PREVENTIVE ACTION HAS BEEN CREATED FOR THIS COMPLAINT. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2015 THAT A CUSTOMER HAD AN ISSUE WITH A LAP SPONGE. THE CUSTOMER STATES THAT A PROCEDURE WAS PERFORMED IN A MALE PATIENT. WHEN THE ASSISTANT COUNTED THE MEDICAL SUPPLIES THAT WERE USED IN THE PROCEDURE, HE/SHE REALIZED THAT A SPONGE WAS MISSED. A X-RAY EXAM WAS PERFORMED IN ORDER TO DETECT IF IT WAS INSIDE THE THORAX OR ABDOMINAL CAVITY OF THE PATIENT BUT IT WAS NOT DETECTED. THE PHYSICIAN DECIDED TO REMOVE IT FROM THE PATIENT. IT WAS POSSIBLE TO SEE THE DETECTABLE BAND OF THE REMOVED SPONGE BY X-RAY EXAM BUT IT WAS NOT DETECTED WHEN IT WAS INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304362 6522 LAP SPG 18X18 STR P-WX200 LAP SPONGE EFQ COVIDIEN 6522 140000620262X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other