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

Model Number	FB-241K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Pneumonia (2011); Pneumothorax (2012); Respiratory Failure (2484)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This report has been submitted by the importer under this mdr report number 2429304 - 2022 - 00062.
Event or Problem Description
Olympus reviewed the following literature titled "improved diagnostic yield and specimen quality with endobronchial ultrasound-guided forceps biopsies: a retrospective analysis." background.Endobronchial ultrasound (ebus) transbronchial needle aspiration (tbna) has a high diagnostic yield when evaluating mediastinal and hilar lymphadenopathy (lad).Having previously demonstrated the safety of ebus-guided cautery-assisted transbronchial nodal forceps biopsy (ca-tbfb), we report disease-specific improvements in diagnostic yield and tissue acquisition when supplementing the ebus-tbna¿based standard of care (soc)with ca-tbfb.Methods.We retrospectively reviewed 213 patients who sequentially underwent soc and ca-tbfb during the same procedure.We determined 3 clinical scenarios of interest based on preprocedural imaging: isolated mediastinal/hilar lad, lad associated with a nodule or mass suspicious for malignancy, and lad associated with parenchymal findings suggestive of sarcoidosis.Using validated methods, we assessed diagnostic yield on a per-patient basis and specimen quality on a per-node basis on the 136 patients meeting diagnostic criteria.Results.Administration of disease-specific soc with ca-tbfb yielded gains that varied by diagnosis.Diagnostic yields of soc and its supplementation with catbfb were 91.8% and 93.4% (p [.50) of the 61 patients diagnosed with solid-organ malignancy, 62.7% and 94.9% (p <.001) of the 59 patients diagnosed with sarcoidosis, and 62.5% and 93.8% (p [.042) of the 16 patients diagnosed with lymphoma, the.For each disease process, specimens obtained with ca-tbfb exhibited statistically higher quality.Conclusions.We suggest that relative to soc, ca-tbfb improves diagnostic yield for sarcoidosis and lymphoma while providing uniformly better tissue quality and cellularity.We propose a protocol for use of this innovative technique.The following adverse events were reported by the authors: pneumomediastinum within 48 hours, pneumonia within 10 days, pneumothorax within 48 hours, respiratory failure, hemoptysis within 1 wk.This article includes 5 reports as follows: (b)(4): bf-uc180f, (b)(4): eu-me1, (b)(4): na-201sx-4022, (b)(4): kd-31c-1, (b)(4): fb-241k.This report is 5 of 5 for (b)(4): fb-241k.
Event or Problem Description
The author responded to our request for additional information as follows: the study took a retrospective look at procedures which were done for a variety of clinical indications.Similarly, most of these patients had multiple other procedures performed during the cases.It is impossible to tease out which aspect of each procedure caused any of the complications.For example, the 4 patients with pneumothorax in the study all underwent transbronchial biopsies, for which pneumothorax is a known complication.The olympus device serial/lot numbers are not available.None of the events were caused by olympus devices directly, but by the procedure using them.Pneumothoraces for example occur 2-6% of the time transbronchial biopsies are taken and were an expected outcome.Pneumomediastinum can occur during any ebus procedure.The other events are likely complications of the overall procedure in patients with advanced disease.None of these were felt to be caused directly by the olympus products.No additional information available regarding medical/surgical intervention.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the author and the legal manufacturer's investigation.New information added to the following fields: b5, h6, h10.The device history records (dhr) for this device could not be reviewed since the serial number was not provided.Olympus ships devices manufactured according to all applicable procedures and meet final product release criteria.A definitive root cause was not identified.Based on the available information, the legal manufacturer was unable to determine the probable cause of the adverse events since the device was not returned for evaluation.No malfunctions were reported.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide corrections to the previous supplemental report with information inadvertently left out of h6.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15429337
• Report Number: 9614641-2022-00318
• Device Sequence Number: 14640240
• Product Code: EOQ
• UDI-Device Identifier: 04953170158087
• UDI-Public: 04953170158087
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2023

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-241K
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 09/20/2022; 04/26/2023
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/17/2022; 05/12/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK LOT: NA-201SX-4022, KD-31C-1.; UNK SERIAL: BF-UC180F, EU-ME1.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown