BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PITUITARY RONGEUR (GRASPER)

    MDR report key: 3370203 · Received July 10, 2013

    Report

    Report Number
    3370203
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 10, 2013
    Manufacturer
    INNOMED INC
    Product Code
    HTX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD LEFT TOTAL KNEE REPLACEMENT AND X-RAY DONE POST-OPERATIVELY REVEALED FOREIGN BODY IN THE SURGICAL AREA. PT RETURNED TO SURGERY THE FOLLOWING DAY FOR REMOVAL OF FOREIGN BODY. FOREIGN BODY REMOVED AND IDENTIFIED BY THE SURGEON AS A SCREW FROM A RONGEUR FROM THE TOTAL KNEE RETRACTOR TRAY. ALL FOUR TOTAL KNEE RETRACTOR TRAYS LOCATED IN THE OPERATING ROOM WERE OPENED AND INSPECTED WITH ONE GRASPER MISSING A SCREW. FOREIGN BODY APPEARS TO BE THE SAME TYPE OF SCREW IN THE OTHER GRASPERS (RONGEUR) FROM THE OTHER TOTAL KNEE RETRACTOR TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319689 PITUITARY RONGEUR (GRASPER) HTX INNOMED INC 1790-03 08071

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R