BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEAL INTUBATION FIBERSCOPE

    MDR report key: 12264526 · Received August 2, 2021

    Report

    Report Number
    8010047-2021-09681
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Report Date
    October 4, 2021
    Product Code
    EOQ
    PMA / PMN Number
    K981543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THE RESULT OF THE DEVICE INSPECTION BY OLYMPUS KOREA CO., LTD. (OKR), BUT COULD NOT IDENTIFY ANY DEFECTS THAT COULD AFFECT THE OCCURRENCE OF THE REPORTED EVENT. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INFORMATION BELOW, THE INSERTION SECTION MAY HAVE BEEN SCRATCHED BY PHYSICAL STRESS AND THE COATING MAY HAVE PEELED OFF FROM THE LOCATION. -ACCORDING TO THE DEVICE INSPECTION RESULT, THE INSERTION SECTION WAS SCRATCHED AND THE COATING WAS PEELED OFF. -ACCORDING TO THE PAST SIMILAR CASES, IT WAS PRESUMED THAT THE COATING ON THE INSERTION PART WAS PEELED OFF DUE TO PHYSICAL STRESS OR THE LIKE. THE INSTRUCTION MANUAL STATES THAT A VISUAL INSPECTION OF THE SURFACE OF THE INSERTION TUBE SHOULD BE PERFORMED. BY FOLLOWING THIS INSTRUCTION, THE USER WILL BE ABLE TO PROPERLY DETECT THE REPORTED EVENT. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AT OKR. AS A RESULT OF THE EVALUATION, THE FOLLOWING WAS CONFIRMED. THE UPWARD ANGULATION WAS OUT OF THE STANDARD DUE TO THE WORN ANGLE WIRE. THE INSERTION TUBE WAS CRUSHED. THE INSIDE OF THE BODY CONTROL UNIT WAS CORRODED. THE DOTS WAS DISPLAYED ON THE ENDOSCOPIC IMAGE BECAUSE THE LIGHT GUIDE BUNDLE WAS BROKEN. THE LIGHT GUIDE BUNDLE WAS ABNORMAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(6) CO., LTD. (OKR) AND FOUND THAT THE COATING OF THE INSERTION TUBE GREATER THAN 1X1 SQUARE MILLIMETER WAS PEELED OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161084 TRACHEAL INTUBATION FIBERSCOPE TRACHEAL INTUBATION FIBERSCOPE EOQ LF-TP

    Patients

    Seq Age Sex Outcome Treatment
    1