BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE

    MDR report key: 6677524 · Received June 29, 2017

    Report

    Report Number
    2951238-2017-00432
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Report Date
    March 19, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    PMA / PMN Number
    PK042140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM EOQ TO PSV.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, USER HANDLING AND IMPROPER MAINTENANCE OF THE DEVICE COULD NOT BE RULED OUT AS CONTRIBUTORY FACTORS TO THE REPORTED TIP BREAKAGE. THE INSTRUCTION MANUAL PROVIDES CAUTION AND WARNING STATEMENTS IN AN EFFORT TO PREVENT DISTAL END BREAKAGE. ¿DO NOT APPLY EXCESSIVE FORCE TO OR BEND THE DISTAL END OF THE ENDOSCOPE. INSTRUMENT DAMAGE MAY OCCUR. BEFORE EACH CASE, PREPARE AND INSPECT THIS INSTRUMENT AS INSTRUCTED BELOW. INSPECT OTHER EQUIPMENT TO BE USED WITH THIS INSTRUMENT AS INSTRUCTED IN THEIR RESPECTIVE INSTRUCTION MANUALS. SHOULD THE SLIGHTEST IRREGULARITY BE SUSPECTED, DO NOT USE THIS INSTRUMENT. USING THE INSTRUMENT THAT IS NOT FUNCTIONING PROPERLY MAY COMPROMISE PATIENT OR OPERATOR SAFETY AND MAY RESULT IN MORE SEVERE EQUIPMENT DAMAGE.¿

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DISTAL END OF THE SCOPE THAT THE BALLOON GOES OVER BROKE OFF. IT WAS ALSO REPORTED THAT THE EDGES OF THE TIP WAS ROUGH. THE DEVICE FRAGMENT DID NOT FALL INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458432 EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE ULTRASONIC BRONCHOFIBERVIDEOSCOPE PSV OLYMPUS MEDICAL SYSTEMS CORP. BF-UC160F-OL8 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1