BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 20598961 · Received November 4, 2024

    Report

    Report Number
    9614641-2024-02056
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    September 20, 2024
    Report Date
    November 19, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    EOQ
    UDI-DI
    04953170158209
    PMA / PMN Number
    K950636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6).

    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, IT IS LIKELY THAT THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A PROCEDURE USING THE SUBJECT DEVICE. 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.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "BRONCHIAL BRANCH TRACING NAVIGATION IN ULTRATHIN BRONCHOSCOPY-GUIDED RADIAL ENDOBRONCHIAL ULTRASOUND FOR PERIPHERAL PULMONARY NODULE." LITERATURE SUMMARY: THIS STUDY AIMED TO DESCRIBE THE PERFORMANCE OF BRONCHIAL BRANCH TRACING (BBT) AS THE SOLE NAVIGATION METHOD IN NAVIGATING ULTRATHIN BRONCHOSCOPE RADIAL ENDOBRONCHIAL ULTRASOUND (UTB-REBUS) PROCEDURES FOR PATIENTS WITH SMALL PERIPHERAL PULMONARY LESIONS (PPLS) BY ASSESSING BOTH THE NAVIGATION SUCCESS AND THE DIAGNOSTIC YIELD. A TOTAL OF 47 PATIENTS WITH A MEAN AGE OF 61.6 (SD 9.53) YEARS WERE INVOLVED IN THIS STUDY. THE MEDIAN PROCEDURE TIME FROM THE INITIATION OF ANAESTHESIA TO THE CONCLUSION OF THE PROCEDURE WAS 40.0 (IQR 30.0¿45.0) MINUTES. THE NAVIGATION SUCCESS USING BBT NAVIGATION WAS 91.5%. THE INDEX DIAGNOSTIC YIELD WAS 82.9%, AND AT 12 MONTHS OF FOLLOW-UP, THE FINAL DIAGNOSTIC YIELD INCREASED TO 91.5%. THE OVERALL DIAGNOSTIC YIELD FOR FORCEPS BIOPSY WAS 84.6% AND 94.1% FOR CRYOBIOPSY, P>0.05. IN CONCENTRIC-ORIENTED REBUS LESIONS, BOTH FORCEPS AND CRYOBIOPSY ACHIEVED A 100% DIAGNOSTIC YIELD. THE DIRECT BRONCHUS SIGN WAS THE ONLY FACTOR ASSOCIATED WITH A BETTER FINAL DIAGNOSTIC YIELD (97.3% VS. 70.0%, P<0.01). RESULTS: THERE WAS ONE CASE OF PNEUMOTHORAX IN OUR COHORT. OVERALL, BLEEDING COMPLICATIONS OCCURRED IN 38.4% OF CASES, WITH THE MAJORITY (27.7%) BEING GRADE 1. NO SEVERE BLEEDING OR DEATHS WERE OBSERVED IN OUR COHORT. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PNEUMOTHORAX - 1 PATIENT BLEEDING > GRADE 0 - 29 PATIENTS > GRADE 1 (BLEEDING IS SELF-LIMITING AND RESOLVES WITH SUCTIONING FOR LESS THAN 1 MINUTE) - 13 PATIENTS > GRADE 2 (BLEEDING REQUIRES SUCTIONING FOR MORE THAN 1 MINUTE, REPEAT WEDGING OF THE BRONCHOSCOPE, OR INSTILLATION OF A HEMOSTATIC AGENT) - 2 PATIENTS > GRADE 3 (BLEEDING NECESSITATES BALLOON BLOCKADE FOR LESS THAN 20 MINUTES OR PREMATURE TERMINATION OF THE PROCEDURE) - 3 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2161047 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS EOQ AOMORI OLYMPUS CO., LTD. FB-231D 04953170158209

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention BF-MP190F| CRYOPROBE BY ERBE| UM-S20-17S