BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IRR FCP BAY BIP 8 3/4 1.0

    MDR report key: 1131383 · Received August 12, 2008

    Report

    Report Number
    1226348-2008-00221
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 22, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. 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 MFG RECORDS HAVE BEEN REVIEWED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MFG AND QUAL TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVAL THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVAL NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED. ADDITIONALLY, THE USE OF NON-INSULATED BIPOLAR FORCEPS IN CONFINED SPACES (E.G. TONSILLECTOMY) MAY RESULT IN UNINTENDED CONTACT WITH AND POSSIBLE INJURY TO NON-TARGET TISSUE DURING THE APPLICATION OF POWER TO THE FORCEPS. THE USE OF INSULTED FORCEPS IS RECOMMENDED FOR SUCH PROCEDURES. IT SHOULD ALSO BE MENTIONED THAT ACCORDING TO THE DEVICE LOT CODE, IT APPEARS THAT THIS DEVICE IS 17 YRS OLD.

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY FOR CONTROL OF OROPHARYNGEAL BLEEDING POST TONSILLECTOMY USING BIPOLAR UNISULATED FORCEPS. AFTER SURGERY, IT WAS NOTED THAT APPROX 1/2 CM WHITE WOUND WAS NOTED AT THE RIGHT ORAL COMMISSURE. PT WAS SENT HOME 2 DAYS LATER WITH INSTRUCTIONS TO INCLUDE FOLLOW UP CARE FOR WOUND. THE DEVICE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRR FCP BAY BIP 8 3/4 1.0 ELECTROSURGICAL CUTTING AND COAGULATION DEVICE GEI CODMAN & SHURTLEFF, INC. NA 9106N

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR