BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 3032156 · Received March 7, 2013

    Report

    Report Number
    8010047-2013-00047
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO ABOUT THE REPORTED EVENT. THE USER FACILITY REPORTED THAT THE PROCEDURE WAS INTERRUPTED AND THE PT WAS DISCHARGED. THE USER REPORTEDLY APPLIED POLYETHYLENE GLYCOL FOR LUBRICATION ON THE INSERTION TUBE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE EXTERIOR PORTION OF THE INSERTION TUBE WAS PEELING, AND APPEARED TO BE CONSISTENT WITH CHEMICAL DAMAGE. THERE WAS RESIDUE OF POLYETHYLENE GLYCOL ON THE PEELED PIECES. THE INSERTION TUBE PEELING WAS ATTRIBUTED TO CHEMICAL DAMAGE FROM A POLYETHYLENE GLYCOL, WHICH IS NOT RECOMMENDED BY OLYMPUS. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE EXTERIOR PORTION OF THE INSERTION TUBE PEELED DURING AN INTUBATION PROCEDURE FOR A LAPAROSCOPIC PNEUMECTOMY, AND THE PEELED PIECES FELL OFF INTO THE PT'S TRACHEA. THE PHYSICIAN REMOVED THE PEELED PIECES FROM THE PT WITH AN UNSPECIFIED DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98451 OLYMPUS TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION SCOPE EQN OLYMPUS MEDICAL SYSTEMS CORPORATION LF-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR