BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EPISTAXIS AIRWAY, 6ML

    MDR report key: 1933847 · Received December 7, 2010

    Report

    Report Number
    9610520-2010-00015
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    July 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    WILLY RUESCH GMBH
    Product Code
    EMX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS SENT DIRECTLY TO THE MFG SITE IN (B)(4). THE RETURNED DATE IS UNK. EVAL: REVIEW OF MFG PROCESS. RESULTS: THE VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED STRONG TRACES OF USAGE AND DAMAGES. THE TIP IS TORN AT ABOUT 1.5CM DIRECTLY AT THE BALLOON WINDING. THE INFLATION LINE IS TORN OUT. THE BALLOON WINDINGS ARE CONTAMINATED. THE TUBE SHAFT IS DAMAGED IN THE AREA OF THE PRODUCT MARKINGS. A REVIEW OF THE MFG PROCESS AND THE USED RAW MATERIAL DID NOT SHOW ANY IRREGULARITIES. THE REVIEW OF THE COMPLAINT DATABASE AS OF (B)(6) 2008 TO PRESENT SHOWED ONE OTHER COMPLAINT FORT THIS ISSUE. CONCLUSIONS: THE CONDITION OF THE RETURNED DEVICE SHOWED THAT STRONG PULLING FORCES HAVE BEEN APPLIED ON THE TUBE TIP AND THE INFLATION LINE SO THAT THEY WERE HEAVILY TORN. MOST PROBABLY THE OBSERVED DAMAGES WERE PROCEDURE RELATED. THE MFG SITE WILL MONITOR THIS PRODUCT WITH REGARD TO THIS REPORTED COMPLAINT DESCRIPTION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE VESSEL ISN'T AIR TIGHT. ADDITIONAL INFO SUGGESTS THAT THE INFLATION SYSTEM OR THE BALLOON IS NOT TIGHT/LEAKING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH EPISTAXIS AIRWAY, 6ML EPISTAXIS AIRWAY EMX WILLY RUESCH GMBH NA 09431

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK