BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEP

    MDR report key: 193466 · Received October 27, 1998

    Report

    Report Number
    1721520-1998-00003
    Event Type
    Other
    Date Received
    October 27, 1998
    Date of Event
    September 17, 1998
    Report Date
    October 27, 1998
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON THURSDAY, 17 SEPTEMBER 1998, PRELIMINARY INFORMATION WAS RECEIVED BY THE INNERDYNE, INC, QUALITY COMPLIANCE DEPARTMENT FROM SALES REPRESENTATIVE, REGARDING ONE (1) INCIDENT INVOLVING A 10MM STEP DISPOSABLE PRODUCT. NUMEROUS ATTEMPTS WERE UNDERTAKEN TO CONFIRM THE REPORTED INFORMATION THROUGH THE INVOLVED PHYSICIAN, WITH DEFINITIVE RESPONSE PROVIDED ON TUESDAY, 27 OCTOBER 1998. THE EPISODE OCCURRED DURING A LAPAROSCOPY PROCDURE ON A PATIENT UNDER THE HAND OF DR. THE STEP PRODUCT WAS SUCCESSFULLY PLACED, WITH THE WORKING CHANNEL ESTABLISHED. A 5MM REDUCER CAP WAS PLACED ON THE 10MM HUB, FOR PASSAGE OF SURGICAL INSTRUMENTS. DURING ROUTINE PASSAGE OF AN ULTRASONIC INSTRUMENT (IE, HARMONIC SCALPEL) INTO THE WORKING CHANNEL, THE INNER DIAMETER (ID) OF THE REDUCER CAP WAS DISLODGED. THE DISLODGED MATERIAL WAS NOT LOCATED, NOR COULD IT BE ACCOUNTED FOR. AN EXPLORATORY SEARCH WAS UNDERTAKEN, WITH NOTHING LOCATED. THE REMAINING PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE PROCEDURE WAS BROUGHT TO CONCLUSION AND THE PATIENT WAS CLOSED, TAKEN TO RECOVERY, AND IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE. 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 NOT UNDERTAKEN. THE INVOLVED PRODUCT WAS RETURNED TO INNERDYNE, INC, AND AN INVESTIGATION HAS BEEN COMPLETED AND DOCUMENTED ACCORDING TO ESTABLISHED PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP 10MM S/C/D GCJ INNERDYNE, INC. S101010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other