BEUDAMED
    FDA Adverse Event Other Summary report: N

    STEP REPOSABLE 12MM CANNULA

    MDR report key: 260436 · Received January 28, 2000

    Report

    Report Number
    1721520-2000-00001
    Event Type
    Other
    Date Received
    January 28, 2000
    Date of Event
    December 20, 1999
    Report Date
    January 21, 2000
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTABLE EVENT: ON FRIDAY, 01/21/2000, DEFINITIVE AND CONFIRMING INFORMATION WAS REC'D BY THE INNERDYNE, INC., QUALITY COMPLIANCE DEPARTMENT FROM HOSPITAL RISK MANAGEMENT DEPARTMENT, REGARDING ONE (1) INCIDENT INVOLVING A REPOSABLE STEP PRODUCT. THE EPISODE OCCURRED AT THE HOSPITAL DURING A LAPAROSCOPIC PROCEDURE. UPON REMOVAL OF THE PLACED ACCESS SYSTEM, IT WAS NOTICED THAT A 1/4" X 3/4" PIECE OF THE DISTAL END OF THE CANNULA BARREL WAS MISSING. THE ATTENDING PHYSICIAN REPORTED TO RISK MANAGEMENT THAT A PIECE OF THE BARREL HAD BEEN LEFT BEHIND, BUT PRESENTED NO PRESENT OR FUTURE COMPLICATION TO THE PT. THE PT WAS INFORMED OF THE MATTER BY DR. THE PT IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE FROM THIS EPISODE. THEREFORE, THE EVENT IS REPORTED AS A RESULT OF UNRETRIEVAL OF FOREIGN MATERIALS, ALTHOUGH NO PT INJURY AND/OR SECONDARY SURGICAL INTERVENTION ARE REPORTED BY THE UTILIZING INSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEP REPOSABLE 12MM CANNULA REPOSABLE CANNULA GCJ INNERDYNE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other