BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2081880 · Received April 5, 2011

    Report

    Report Number
    2523190-2011-00016
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    INTEGRA, YORK - ISURGICAL
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A ROBOT-ASSISTED LAPAROSCOPIC HYSTERECTOMY. SURGERY ITSELF WAS UNEVENTFUL. AFTER COMPLETION OF SURGERY AND DURING EQUIPMENT CHECK, IT WAS NOTED THAT A SMALL PIN (ABOUT 5MM IN LENGTH) WAS MISSING FROM THE END OF THE LAPAROSCOPIC TENACULUM. IT WAS THE PIN THAT HOLDS THE PINCERS OF THE INSTRUMENT TOGETHER. THE SURGICAL TECH AND ASSISTANT SURGEON WERE INTERVIEWED. THE MAIN SURGEON WAS AT THE CONSOLE AND NOT INVOLVED USING THE TENACULUM. THE ASSISTANT SURGEON STATED HE CANNOT REMEMBER IF THE INSTRUMENT WAS INTACT AFTER HE WITHDREW FROM THE PATIENT (THE ROOM WAS DARKENED), BUT HE FEELS IT WAS IN PROPER WORKING CONDITION. THE SURGICAL TECH WAS LESS CERTAIN THAT IT WAS INTACT AFTER USAGE. THEREFORE, THE ASSUMPTION IS THAT THE PIN WAS POSSIBLY RETAINED BY THE PATIENT. IF THE PIN WAS RETAINED THE SURGEON FELT THAT IT WAS TOO SMALL TO BE IDENTIFIABLE BY RADIOLOGY AND UNSAFE TO TRY AND RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE HIH INTEGRA, YORK - ISURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR