BEUDAMED
    FDA Adverse Event Other Summary report: N

    REPOSABLE STEP

    MDR report key: 213529 · Received March 10, 1999

    Report

    Report Number
    1721520-1999-00003
    Event Type
    Other
    Date Received
    March 10, 1999
    Date of Event
    March 3, 1999
    Report Date
    March 9, 1999
    Manufacturer
    INNERDYNE, INC.
    Product Code
    DYB
    Removal / Correction Number
    900958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON WEDNESDAY, 3 MARCH 1999, INFO WAS REC'D BY THE INNERDYNE, INC., QUALITY COMPLIANCE DEPT FROM SALES REPRESENTATIVE REGARDING ONE INCIDENT INVOLVING A 10MM REPOSABLE STEP PRODUCT. THE EPISODE OCCURRED AT THE HOSP, DURING A LAPAROSCOPY PROCEDURE ON A PT UNDER THE HAND OF THE DR. THE STEP PRODUCT WAS PLACED, WITH THE WORKING CHANNEL ESTABLISHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AT THE CONCLUSION OF THE PROCEDURE AND WITHDRAWAL OF THE PRODUCT, IT WAS NOTICED THAT DAMAGE TO THE DISTAL TIP OF THE CANNULA BARREL HAD OCCURRED WITH TWO DISPLACED FRAGMENT SITES. THE PT WAS REENTERED WITH EXPLORATION UNDERTAKEN. ONE OF THE FRAGMENTS WAS LOCATED WHILST THE SECOND FRAGMENT WAS NOT LOCATED, NOR COULD IT BE ACCOUNTED FOR. THE PROCEDURE WAS BROUGHT TO CONCLUSION AND THE PT 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. CONFIRMATION, ONE WAY OR THE OTHER, COULD NOT BE ESTABLISHED. SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE, WAS 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 REPOSABLE STEP 10MM REPLACEMENT BARRELL DYB INNERDYNE, INC. RS901010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other