BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 2923105 · Received January 18, 2013

    Report

    Report Number
    1226348-2013-11188
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 12, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE LOT HISTORY RECORDS CONFIRMED THAT THIS LOT WAS PRODUCED WITHIN SPECIFICATION. THE TWO DAMAGE SAMPLES WERE REVIEWED AND WERE FOUND TO BE ACCEPTABLE PER SPECIFICATION. ALL PULL TESTS (WHICH ENSURE PROPER BOND BETWEEN THE STRING AND PATTIE) WERE REVIEWED AND FOUND TO BE WITHIN ACCEPTABLE LIMITS. RETURNED PRODUCT WAS PULL TESTED AND RECORDED. RETURNED PRODUCT WAS OBSERVED TO HAVE DATA POINTS FROM 2.4 - 4.1 (LBS) WHICH IS ABOVE SPECIFICATION. THEREFORE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT A PATTIE WAS LOST IN A PATIENT WHEN BEING REMOVED FOLLOWING HOMEOSTASIS. THE STRING WAS REMOVED FROM THE PATIENT BUT NOT THE PATTIE AS IT HAD BECOME DETACHED AND WAS LEFT IN THE SURGICAL SITE. TISSEEL HAD BEEN PLACED INTO THE SURGICAL SITE WHICH HAD TO BE REMOVED TO SEARCH FOR THE PATTIE. FORTUNATELY THE PATTIE WAS FOUND BUT A 2ND APPLICATION OF TISSEEL NEEDED TO BE OPENED. THE 2ND INCIDENT OCCURRED WHEN A NEW PACKET OF PATTIES WERE OPENED FOR USE ON THE SAME PATIENT - THE STRING DETACHED FROM THE PATTIE WITH NO FORCE WHEN BEING TAKEN OF THE PATTIE CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28352 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF, INC 244030

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention