BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL PATTIE, 1/2 X 1/2

    MDR report key: 3594928 · Received January 28, 2014

    Report

    Report Number
    1226348-2014-11182
    Event Type
    Injury
    Date Received
    January 28, 2014
    Date of Event
    January 16, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FQA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION. DUE TO NOT BEING ABLE TO EVALUATE THE PRODUCT UNDER QUESTION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. A REVIEW OF THE DEVISE HISTORY RECORDS FOR THE SUBJECT DEVICE DID NOT REVEALED ANY ANOMALIES. THESE LOT CODES APPEAR TO HAVE MET ALL TESTING REQUIREMENT, THERE WERE NO ANOMALIES NOTED DURING MANUFACTURING PROCESS. LOT # 415306 WAS USED TO VERIFY CAPABILITY OF A NEW BRANSON ULTRASONIC WELDER. ALL PULL TEST DATA WAS FOUND TO BE ACCEPTABLE. WHILE THERE IS VARIATION INHERENT IN OUR MANUFACTURING PROCESS OF THE COTTONOID MATERIAL, OUR OBJECTIVE IS TO PRODUCE PRODUCT WITH THE LEAST POSSIBLE AMOUNT OF LINTING. THEREFORE LOT TO LOT VARIATION IN THE COTTONOID PROCESS MAY RESULT IN LOTS THAT LINT MORE OR LESS THAN THE NORM. "FRAYING" CAN ALSO COME FROM THE QUALITY OF THE EDGE CUT FROM THE SLITTING PROCESS, BUT IT IS NOT POSSIBLE TO DETERMINE THIS IS AN ISSUE SINCE IT IS NOT POSSIBLE TO EVALUATE THE PRODUCT UNDER QUESTION. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. AT THIS TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED, SHOULD THE PRODUCT BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE REOPENED AND AN INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED: SURGEON SAID THE PATTIES WERE FRAYING DURING THE PROCEDURE. HE COULD SEE THEM FRAY UNDER THE MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60913 SURGICAL PATTIE, 1/2 X 1/2 SURGICAL SPONGE FQA CODMAN & SHURTLEFF, INC. 424137, 415306, 424140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention