BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASONIC PROBE

    MDR report key: 17878597 · Received October 5, 2023

    Report

    Report Number
    3002808148-2023-10828
    Event Type
    Injury
    Date Received
    October 5, 2023
    Date of Event
    September 7, 2023
    Report Date
    November 28, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ITX
    UDI-DI
    04953170368479
    PMA / PMN Number
    K982323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 SERIAL AND/OR 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. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLOSE-TO-LESION TRANSBRONCHIAL BIOPSY: A NOVEL TECHNIQUE TO IMPROVE SUITABILITY OF SPECIMENS FOR GENETIC TESTING IN PATIENTS WITH PERIPHERAL PULMONARY LESIONS". LITERATURE SUMMARY BRONCHOSCOPY WITH RADIAL-PROBE ENDOBRONCHIAL ULTRASOUND, A GUIDE SHEATH, AND ELECTROMAGNETIC NAVIGATION CAN IMPROVE THE DIAGNOSTIC YIELD OF PERIPHERAL LUNG NODULES. HOWEVER, THE SUITABILITY OF SPECIMENS FOR GENETIC ANALYSIS REMAINS UNSATISFACTORY. WE HYPOTHESIZED THAT A TRANSBRONCHIAL BIOPSY PERFORMED AFTER CLOSELY APPROACHING THE BRONCHOSCOPE TIP TO THE LESION MIGHT PROVIDE MORE SUITABLE SPECIMENS FOR GENETIC ANALYSIS. WE ENROLLED 155 PATIENTS WITH PERIPHERAL PULMONARY LESIONS WHO UNDERWENT BRONCHOSCOPY WITH A THIN OR ULTRATHIN BRONCHOSCOPE. BRONCHOSCOPY WAS PERFORMED USING VIRTUAL BRONCHOSCOPIC NAVIGATION AND RADIAL-PROBE ENDOBRONCHIAL ULTRASOUND WITH A GUIDE SHEATH. THE BRONCHOSCOPE TIP WAS PLACED CLOSER TO THE LESION DURING BRONCHOSCOPY TO COLLECT LARGER SPECIMENS WITH HIGHER MALIGNANT CELL CONTENT. THE PATIENTS WHO UNDERWENT A CLOSE-TO-LESION BIOPSY HAD HIGHER RATES OF OVERALL DIAGNOSTIC YIELD, HISTOPATHOLOGICAL DIAGNOSTIC YIELD, AND SPECIMEN QUALITY FOR GENETIC TESTING THAN THOSE WHO DID NOT. THE SIGNIFICANT DETERMINANTS OF THE SPECIMEN¿S SUITABILITY WERE THE CLOSE-TO-LESION APPROACH, WITHIN-THE-LESION IMAGE, THE USE OF STANDARD 1.9-MM-FORCEPS, AND THE NUMBER OF CANCER-CELL-POSITIVE SPECIMENS. THE SIGNIFICANT PREDICTORS OF THE SPECIMEN¿S SUITABILITY FOR GENETIC ANALYSIS WERE CLOSE-TO-LESION BIOPSY AND THE NUMBER OF MALIGNANT CELL-POSITIVE TISSUE SAMPLES. THIS STUDY DEMONSTRATES THAT THE CLOSE-TO-LESION TRANSBRONCHIAL BIOPSY SIGNIFICANTLY IMPROVES THE SUITABILITY OF BRONCHOSCOPIC SPECIMENS FOR GENETIC ANALYSIS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. EVENT 1: GRADE 3 ANOREXIA IN 1 PATIENT. EVENT 2: GRADE 3 PNEUMONIA IN 2 PATIENTS. EVENT 3 : HYPOXEMIA IN 2 PATIENTS. TWO PATIENTS IN THE CL-TBB GROUP REQUIRED HOSPITALIZATION, ONE PATIENT HAD GRADE 3 ANOREXIA, AND ONE PATIENT HAD GRADE 3 PNEUMONIA. ALSO, IN THE NON-CL-TBB GROUP- 3 PATIENTS REQUIRED HOSPITALIZATION, TWO HAD GRADE 3 HYPOXEMIA, AND ONE PATIENT HAD GRADE 3 PNEUMONIA. NO PNEUMOTHORAX, BLEEDING, OR BRONCHIAL TEARS THAT NEEDED THERAPEUTIC INTERVENTION OCCURRED IN EITHER GROUP. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1, (B)(6 )(BF-P290) 2, (B)(6) (PW-6C-1) 3, (B)(6) (UM-S20-17S) 4, (B)(6) (K-202) THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2020949 ULTRASONIC PROBE ULTRASONIC PROBE ITX SHIRAKAWA OLYMPUS CO., LTD. UM-S20-17S 04953170368479

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization EVIS LUCERA ELITE BRONCHOVIDEOSCOPE- SERIAL UNK| SINGLE USE GUIDE SHEATH KIT ¿ LOT UNKNOWN| SPRAY CATHETER ¿ LOT UNKNOWN