BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCISSOR 63/4 STR MAYO BVL

    MDR report key: 2143040 · Received June 23, 2011

    Report

    Report Number
    1226348-2011-00231
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    HRR
    PMA / PMN Number
    PRE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION 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

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

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE METZENBAUM SHEARS TIP BROKE DURING THE SURGERY INSIDE THE ABDOMINAL CAVITY. AN X-RAY WAS USED TO LOCATE THE BROKEN PIECE. THE DOCTOR FOUND THE BROKEN PIECE AND IT WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCISSOR 63/4 STR MAYO BVL INSTRUMENT, MANUAL, SURGICAL HRR CODMAN & SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention