BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 18301262 · Received December 11, 2023

    Report

    Report Number
    9614641-2023-01871
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    February 16, 2023
    Report Date
    January 15, 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
    SY
    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 AND TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR (UPDATED FIELD B5). 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 EVENTS 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 LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. REFERENCE DOI: 10.1097/MS9.0000000000000180. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 0

    NO OLYMPUS DEVICE CAUSE OR CONTRIBUTE TO ANY OF THE PATIENT COMPLICATIONS DESCRIBED IN THIS LITERATURE. NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE DESCRIBED IN THIS LITERATURE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OBSERVATIONAL FINDINGS OF TRANSBRONCHIAL LUNG BIOPSY IN PATIENTS WITH INTERSTITIAL LUNG DISEASE: A RETROSPECTIVE STUDY IN ALEPPO UNIVERSITY HOSPITAL." BACKGROUND: CLINICIANS FACE A SIGNIFICANT OBSTACLE WHEN ATTEMPTING TO DIAGNOSE INTERSTITIAL LUNG DISEASE (ILD) PATIENTS. HOWEVER, A THOROUGH CLINICAL EXAMINATION TOGETHER WITH THE PROPER IMAGING AND DIAGNOSTIC TECHNIQUES MAY PROVIDE A RELIABLE DIAGNOSIS OF A PARTICULAR KIND OF ILD, AND INVASIVE TESTS SUCH AS RIGID BRONCHOSCOPY OR SURGICAL LUNG BIOPSY MAY NOT BE NECESSARY. THE AIM OF THIS STUDY IS TO DETERMINE THE HISTOLOGIC OUTCOMES OF AN ILD TRANSBRONCHIAL LUNG BIOPSY (TBLB) CARRIED OUT AT THE UNIVERSITY HOSPITAL IN ALEPPO. METHODS: THIS RETROSPECTIVE COHORT RESEARCH WAS DONE BETWEEN (B)(6) 2020 AND (B)(6) 2022 AT THE PULMONARY DEPARTMENT OF ALEPPO UNIVERSITY HOSPITAL, SYRIA, USING PATIENT RECORDS. IN OUR STUDY, 174 PATIENTS WERE EXAMINED. WE INCLUDED PATIENTS OVER THE AGE OF 18 WHO WERE REFERRED OR ADMITTED TO OUR DEPARTMENT AT ALEPPO UNIVERSITY HOSPITAL AFTER BEING DIAGNOSED WITH DIFFUSE PARENCHYMAL LUNG DISEASE BASED ON HIGH-RESOLUTION COMPUTED TOMOGRAPHY AND CLINICAL SYMPTOMS, WHILE EXCLUDING OTHER RESPIRATORY DISEASES SUCH AS TUBERCULOSIS AND CORONAVIRUS DISEASE 2019. RESULTS: PATIENTS IN THE RESEARCH WERE 53 ± 7.1 YEARS OLD ON AVERAGE. COUGH AND DYSPNEA WERE THE MOST COMMON CLINICAL COMPLAINTS AMONG THE PATIENTS, WHICH ACCOUNTED FOR 79.12 AND 78.16%, RESPECTIVELY. A SIGNIFICANT FRACTION OF GROUND-GLASS OPACITY WAS DETECTED ON THE HIGH-RESOLUTION COMPUTED TOMOGRAPHY, AMOUNTING TO 102 (58.62%) AND 74 (42.53%) FOR THE RETICULAR LESIONS, RESPECTIVELY. AS A COMPLICATION THERE WERE 40 PATIENTS WITH BLEEDING, OF WHOM 24 HAD MODERATE BLEEDING, AND 11 HAD MAJOR BLEEDING. WE ALSO HAD THREE PATIENTS WITH PNEUMOTHORAX. THE DIAGNOSTIC YIELD OF THE TBLB IN OUR ILD PATIENTS WAS 66.66%. CONCLUSION: AN ADEQUATE DIAGNOSTIC ACCURACY (66.66%) WAS DETECTED IN THE TBLB IN CONFIRMING THE DIAGNOSIS OF ILD; IN ADDITION, THE BLEEDING WAS THE MOST PREVALENT COMPLICATION OF THIS PROCEDURE. MORE INTERVENTIONAL STUDIES ARE NEEDED TO COMPARE THE DIAGNOSTIC ACCURACY OF THIS PROCEDURE WITH OTHER INVASIVE AND NONINVASIVE DIAGNOSTIC METHODOLOGIES OF ILD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PNEUMOTHORAX (3) MINOR BLEEDING (29) MAJOR BLEEDING REQUIRING ADRENALIN INFUSION (11) THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) BRONCHOFIBERSCOPE (BF-PE2 SN : UNKNOWN) (B)(6) DISPOSABLE BIOPSY FORCEPS (FB-231D LOT UNKNOWN) THIS COMPLAINT IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072143 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS EOQ AOMORI OLYMPUS CO., LTD. FB-231D 04953170158209

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention