BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHUS SYSTEM EXTENDED WORKING CHANNEL

    MDR report key: 808626 · Received October 19, 2006

    Report

    Report Number
    3004659744-2006-00003
    Event Type
    Malfunction
    Date Received
    October 19, 2006
    Date of Event
    September 15, 2006
    Report Date
    September 15, 2006
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    KPR
    PMA / PMN Number
    k042438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY SUBMITTED INFORMATION REGARDING TWO EVENTS INVOLVING TWO OF THE COMPANY'S EWC. ONE DEVICE WAS RETURNED FROM THE USER FOR THE RETURN PRODUCT ANALYSIS, HOWEVER, IT IS UNCLEAR WHETHER THE DEVICE RETURNED IS THE SUBJECT OF THIS MDR REPORT, OR THE SUBJECT OF MDR NO. 3004659744-2006-00002. INVESTIGATION OF THE RETURNED DEVICE IS ONGOING AND ADDITIONAL INFORMATION WILL BE PROVIDED, IF WARRANTED.

    Description of Event or Problem · 1

    THE PHYSICIAN NAVIGATED TO A SUSPECTED LESION USING THE BRONCHUS SYSTEM, WITHDREW THE LOCATABLE GUIDE FROM THE EXTENDED WORKING CHANNEL (EWC). HE THEN CONFIRMED THE EWC TIP POSITION BY REINSERTING THE LOCATABLE GUIDE. HE DID NOT NOTE RESISTANCE, BUT OBSERVED UNDER FLUOROSCOPY THAT THE LOCATABLE GUIDE WAS EXTENDING THROUGH THE SIDE OF THE EXTENDED WORKING CHANNEL APPROX 2 CM FROM THE DISTAL TIP. THE PROCEDURE WAS DISCONTINUED. UPON EXAMINATION, A "LONGITUDINAL RIP IN THE SIDE OF THE EWC" WAS OBSERVED. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHUS SYSTEM EXTENDED WORKING CHANNEL GUIDING SHEATH FOR CT X-RAY SYSTEM KPR SUPERDIMENSION, LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * BRONCHOSCOPE