MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE

Model Number	KD-640L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Airway Obstruction (1699); Pulmonary Emphysema (1832); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010); Pneumothorax (2012); Loss of consciousness (2418); Pneumoperitoneum (4819)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Olympus reviewed the following literature titled: "effectiveness and safety of full-thickness versus circular muscle myotomy in peroral endoscopic myotomy: a retrospective single-center analysis of 152 patients.¿ literature summary abstract.Background: achalasia is a primary esophageal motility disorder, which shows impaired relaxation of the lower esophageal sphincter (les) and the absence of peristalsis, leading to dysphagia, weight loss, and chest pain.In recent years, peroral endoscopic myotomy (poem) has become a popular method for treating achalasia.However, the effectiveness and safety of full-thickness myotomy (ftm) versus circular muscle myotomy (cmm) in poem require further investigation.Methods: this retrospective single-center analysis studied 152 patients who underwent poem surgery at the general hospital of the western theater command from may 2014 to may 2023.Patients were divided into two groups based on the depth of myotomy: the ftm group and the cmm group.Parameters such as surgical success rate, procedure time, and myotomy length were evaluated, and treatment efficacy was assessed based on the eckardt score.Postoperative complications and efficacy were also monitored.Results: technical success was achieved in both groups, with shorter procedure times in the ftm group (p < 0.05).There were no significant differences in postoperative eckardt scores and symptom improvement between the ftm and cmm groups.The incidence of adverse events was similar in both groups.The incidence of gastroesophageal reflux disease (gerd) seemed to be higher in the ftm group, although this difference was not statistically significant (p = 0.051).Type of adverse events and number of patients: laryngeal edema - 2 patients, subcutaneous emphysema - 16 patients, pneumothorax - 4 patients, pneumoperitoneum - 17 patients, bleeding during procedure - 7 patients, delayed hemorrhage - 14 patients, infection - 7 patients, pleural effusion - 48 patients, impaired consciousness - 1 patient, post-operative pain - 22 patients.Conclusion: for patients with achalasia, there were no significant differences in short-to-medium-term treatment efficacy and safety between ftm and cmm in poem.Although ftm significantly reduced procedure time, it may lead to a higher incidence of gerd.More cases are needed in the future to explore the more appropriate myotomy for different achalasia subtypes.
Event or Problem Description
No additional information was received from the customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer's investigation.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.Olympus will continue to monitor field performance for this device.¿.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22013756
• Report Number: 9614641-2025-00721
• Device Sequence Number: 17478425
• Product Code: KNS
• UDI-Device Identifier: 04953170208423
• UDI-Public: 04953170208423
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: KD-640L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown