MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ELECTROSURGICAL KNIFE; PAPILLOTOMY KNIFE

Model Number KD-31C-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemoptysis (1887); Pneumonia (2011); Pneumothorax (2012); Respiratory Failure (2484); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/30/2019

Event Type  Injury  

Event 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).This report is 4 of 5 for (b)(4).

• Brand Name: ELECTROSURGICAL KNIFE
• Type of Device: PAPILLOTOMY KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 15428127
• MDR Text Key: 299972730
• Report Number: 2429304-2022-00061
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170049323
• UDI-Public: 04953170049323
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2022,09/15/2022

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
• Device Operator: Health Professional
• Device Model Number: KD-31C-1
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK LOT: NA-201SX-4022, FB-241K; UNK SERIAL: BF-UC180F, EU-ME1
• Patient Outcome(s): Other