BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHOVIDEOSCOPE

    MDR report key: 10926401 · Received December 1, 2020

    Report

    Report Number
    8010047-2020-09648
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    October 26, 2020
    Report Date
    January 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170308185
    PMA / PMN Number
    K023984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS AND FOUND THAT THE INSTRUMENT CHANNEL PORT OF THE DEVICE WAS SHAVED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT INVESTIGATE THE DEVICE, BECAUSE THE DEVICE WAS NOT RETURNED TO OMSC. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. SINCE THE DEVICE WAS NOT RETURNED, THE EXACT CAUSE WAS UNKNOWN. BASED UPON THE INFORMATION FROM COMPLAINT, OMSC SURMISED THAT THE UNIVERSAL CORD SURFACE OF THE DEVICE PARTIALLY PEELED OFF DUE TO A STRESS APPLIED FROM OUTSIDE BY FRICTION OF MOUTHPIECES, ENDOTRACHEAL TUBES, ETC. OMSC SURMISED THAT THE INSTRUMENT CHANNEL PORT OF THE DEVICE WAS SHAVED DUE TO THE INSTRUMENT CHANNEL PORT WAS RUBBED BY REPEATED INSERTION OF AN ENDO-THERAPY ACCESSORIES OR BRUSHING.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(6) AND FOUND THAT THE UNIVERSAL CORD SURFACE OF THE DEVICE PARTIALLY PEELED OFF. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391473 BRONCHOVIDEOSCOPE BRONCHOVIDEOSCOPE EOQ OLYMPUS MEDICAL SYSTEMS CORP. BF-1T150 04953170308185

    Patients

    Seq Age Sex Outcome Treatment
    1