BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE USE GUIDE SHEATH KIT

    MDR report key: 13351566 · Received January 25, 2022

    Report

    Report Number
    8010047-2022-01975
    Event Type
    Injury
    Date Received
    January 25, 2022
    Report Date
    April 16, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    EOQ
    UDI-DI
    04953170245466
    PMA / PMN Number
    K060243
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    ON JAN. 5, 2022, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "PREDICTIVE RISK FACTORS FOR PNEUMOTHORAX AFTER TRANSBRONCHIAL BIOPSY USING ENDOBRONCHIAL ULTRASONOGRAPHY WITH A GUIDE SHEATH".THIS STUDY REVIEWED DATA FROM 916 PATIENTS WHO UNDERWENT TRANSBRONCHIAL BIOPSY (TBB) USING ENDOBRONCHIAL ULTRASONOGRAPHY WITH A GUIDE SHEATH (EBUS-GS-TBB) FOR PERIPHERAL SOLITARY LUNG LESIONS BETWEEN AUGUST 2013 AND MARCH 2017.THE MEDIAN AGE OF THE PATIENTS WAS 72[65-77] YEARS, AND 609 PATIENTS WERE MALE. THERE WERE 325 PATIENTS OVER THE AGE OF 75.FOR THE PROCEDURE, OLYMPUS PRODUCTS(EU-M30S, UM S20-20R, BF-260, BF-P260F, BF-P290, BF-1T260, BF-1TQ290, K-201, K-203) WERE USED. IN THE LITERATURE FOR THE PROCEDURE, IT WAS REPORTED THAT THE FOLLOWING.THIRTY PATIENTS DEVELOPED PNEUMOTHORAX AFTER EBUS-GS-TBB, WHICH WAS RESOLVED IN 22 PATIENTS BY OBSERVATION. EIGHT PATIENTS REQUIRED CHEST DRAINAGE, AND FOUR PATIENTS DEVELOPED RESPIRATORY FAILURE ( SPO2 < 90%) WHEN PNEUMOTHORAX OCCURRED. ALL PATIENTS RECOVERED WITHOUT ANY SURGICAL INTERVENTION OR PLEURODESIS.IF THE APEX OF A COLLAPSED LUNG WAS ABOVE THE CLAVICLE ON CHEST X-RAY (POSTEROANTERIOR [PA] UPRIGHT POSITION) AND THE PATIENT DID NOT EXHIBIT SIGNIFICANT DYSPNEA, CLINICAL OBSERVATION WAS OFTEN SELECTED; HOWEVER, IN SOME CASES, CHEST DRAINAGE AND PROLONGED HOSPITALIZATION WERE USED.BASED ON THE AVAILABLE INFORMATION, REPORTED PNEUMOTHORAX WAS NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. HOWEVER, OMSC ASSUMES THAT THE PNEUMOTHORAX MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE PROCEDURE. AND, OMSC ASSUMES THAT THE PNEUMOTHORAX (8 PATIENTS) MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. OMSC ASSUMES THAT THE RESPIRATORY FAILURE WAS NOT SERIOUS AND WAS NOT RELATED TO OLYMPUS PRODUCT BASED ON THE AVAILABLE INFORMATION SUCH AS THE FOLLOWING REPORT:FOUR PATIENTS DEVELOPED RESPIRATORY FAILURE (SPO2<90%) WHEN PNEUMOTHORAX OCCURRED.THEREFORE, OMSC ASSUMES THAT THE PNEUMOTHORAX WAS AN ADVERSE EVENT TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENT (EXCEPT FOR SOME, FOR EXAMPLE, AGE) WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) OF THE SUBJECT DEVICE FOR THE PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831547 SINGLE USE GUIDE SHEATH KIT SINGLE USE GUIDE SHEATH EOQ OLYMPUS MEDICAL SYSTEMS CORP. K-201 04953170245466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R