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	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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).
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• 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: 20598961
• Report Number: 9614641-2024-02056
• Device Sequence Number: 8787409
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2024

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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BF-MP190F; CRYOPROBE BY ERBE; UM-S20-17S
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown