MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-231D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pneumothorax (2012)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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).
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18301262
• Report Number: 9614641-2023-01871
• Device Sequence Number: 6983971
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: SY
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FB-231D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown