BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 2915446 · Received January 15, 2013

    Report

    Report Number
    1226348-2013-10951
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 17, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DEVICE HISTORY RECORDS WERE REVIEWED AND THEY CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. DURING THE INVESTIGATION IT WAS ALSO NOTED THAT 19 SAMPLES BETWEEN THE TWO LOTS WERE TESTED UNDER X-RAY AND THEY SAMPLE PASSED THE TEST REQUIREMENTS. THE INSTRUCTIONS FOR USE WARN HEALTHCARE USERS THAT, 'THIS DEVICE IS CONSIDERED RADIOPAQUE IN ACCORDANCE WITH ASTM F640. THE DEVICE MAY NOT BE VISIBLE UNDER ALL RADIOGRAPHIC CONDITIONS. THE SIZE AND POSITION OF THE MARKER MAY IMPACT RADIOPACITY. IN ADDITION, ADJACENT STRUCTURES MAY INHIBIT VISIBILITY. MULTIPLE ANGLES AND MODIFICATION OF RADIOGRAPHY PARAMETERS (E.G. KEVM MAS) MAY BE REQUIRED TO ENHANCE VISIBILITY OF THE MARKER." 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

    REP REPORTED THAT THE SURGICAL PATTIE BECAME DETACHED FROM THE STRING. THE SURGEON DID NOT KNOW IT HAD COME DETACHED FROM THE STRING. HE HAD A VISUAL OF THE STRING COMING OUT OF THE OPERATING SITE AND WAS OPERATING, MANIPULATING TISSUE, MOVING INSTRUMENTS IN AND OUT OF THE OPERATING SITE, ETC. WHEN HE REMOVED THE STING, THERE WAS NO PATTY ATTACHED. THE TEAM X-RAYED THE PATIENT AND COULD NOT FIND THE MISSING PATTY. THEY COULD NOT FIND IT IN THEIR COUNT. THEY THINK IT IS POSSIBLY STILL INSIDE THE PATIENT. THEY ALSO THINK THAT AN INSTRUMENT MAY HAVE CUT THE STRING AND SEPARATED IT FROM THE PATTY. ADDITIONALLY, THE O.R. TEAM SAID THEY WERE X-RAYING NON USED PATTIES FROM THE SAME SURGERY AND THE PATTIES WERE NOT SHOWING-UP ON X-RAY. THE MORNING I WENT INTO THE FACILITY (B)(6) 2012, THEY X-RAYED PATTIES AGAIN, AND THEY WERE SHOWING-UP ON X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22802 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF, INC 263066 & 244002

    Patients

    Seq Age Sex Outcome Treatment
    1