BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM REPOSABLE BARREL

    MDR report key: 242631 · Received September 29, 1999

    Report

    Report Number
    1721520-1999-00009
    Event Type
    Injury
    Date Received
    September 29, 1999
    Date of Event
    September 22, 1999
    Report Date
    September 29, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GEA
    Removal / Correction Number
    901232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON WEDNESDAY, SEPTEMBER 22, 1999, PRELIMINARY INFO WAS RECEIVED BY THE INNERDYNE, INC, QUALITY COMPLIANCE DEPT FROM SALES REP REGARDING ONE (1) INCIDENT INVOLVING A 12MM CANNULA BARREL FOR THE STEP REPOSABLE PRODUCT. DEFINITIVE AND CONFIRMING INFO WAS REPORTED ON FRIDAY, SEPT. 24, 1999 REGARDING THIS INCIDENT TO THE REGULATORY AFFAIRS DEPT OF THE COMPANY. THE EPISODE OCCURRED AT HOSPITAL DURING A LAPAROSCOPIC PROCEDURE UNDER THE HAND OF DOCTOR. ON SEPT. 22, 1999, A LASER LAPAROSCOPIC GYNECOLOGIC PROCEDURE WAS UNDERTAKEN BY THE PHYSICIAN. AT SOME POINT DURING THE PROCEDURE, IT WAS NOTICED THAT A 2MM TO 4MM FRAGMENT OF THE DISTAL END OF THE BARREL WAS MISSING. ATTEMPTS TO RETRIEVE THE MISSING FRAGMENT(S) THROUGH THE CANNULA BARREL WERE UNSUCCESSFUL. CONVERSION TO AN OPEN PROCEDURE WAS UNDERTAKEN FOR RETRIEVAL OF THE MISSING FRAGMENT(S), WITH NO PIECE(S) REPORTED TO HAVE BEEN RETRIEVED. THE USER FACILITY WAS CONTACTED FOR STATUS/CONDITION OF THE PT; HOWEVER, SPECIFIC INFO REGARDING THE CASE HAS NOT BEEN RELEASED. THEREFORE, THE EVENT IS REPORTED FOR THE POSSIBLE LEAVING OF A FOREIGN MATERIAL IN THE ABDOMINAL REGION. SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE, WAS UNDERTAKEN. THE INVOLVED PRODUCT HAS NEITHER BEEN RELEASED, NOR RETURNED TO INNERDYNE, INC AT THE TIME OF THIS REPORT, SO AN INVESTIGATION OF THE PRODUCT HAS NOT BEEN POSSIBLE. UPON LEAVING ACCESS TO THE PRODUCT, AN INVESTIGATION WILL BE PERFORMED WITH RESULTING ASSESSMENT FORWARDED TO THE FDA, IN A FOLLOW-UP REPORT, WHEREIN EVALUATION CONCLUSIONS CAN BE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM REPOSABLE BARREL 12MM REPOSABLE BARREL CANNULA GEA INNERDYNE, INC. RS901012 (IBID)

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other