BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1351 (D) BALLOON

    MDR report key: 7379853 · Received March 28, 2018

    Report

    Report Number
    2951238-2018-00220
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 27, 2018
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PSV
    PMA / PMN Number
    PK042140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AND LIMITED INFORMATION WAS PROVIDED BY THE USER FACILITY REGARDING THE REPORTED EVENT. THEREFORE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. PLEASE CROSS REFERENCE MFR# 2951238-2018-00198.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE USER FACILITY AND TO PROVIDE CORRECTION TO THE INITIAL REPORTED EVENT. THE USER FACILITY LATER CONFIRMED THAT THE BALLOON DID NOT FALL OFF THE DISTAL TIP OF THE SCOPE DURING A BRONCHOSCOPY PROCEDURE. AS REFERENCED IN RELATED REPORT (MFR# 2951238-2018-00198), THE USER FACILITY CONFIRMED THAT ONLY THE BALLOON GROOVE AT THE DISTAL TIP OF THE SCOPE BROKE OFF AND FELL INTO THE PATIENT DURING A PROCEDURE.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT THE DEVICE FELL OFF THE DISTAL TIP OF THE BRONCHOSCOPE AND INTO THE PATIENT DURING A BRONCHOSCOPY PROCEDURE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BALLOON FROM THE PATIENT. THERE WAS NO PATIENT HARM/INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223298 MAJ-1351 (D) BALLOON BALLOON PSV OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1351 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS: BF-UC180F, S/N (B)(4).