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

Model Number	KD-611L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	08/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "efficacy of a novel traction method: outside-lesion clip-thread method for gastric endoscopic submucosal dissection of lesions of the greater curvature of the upper/middle stomach (with video)." abstract: background - gastric endoscopic submucosal dissection (esd) for lesions located on the greater curvature of the upper and middle (u/m) third of the stomach remains challenging, even for experienced endoscopists.Accordingly, we have developed a novel traction technique, termed the outside-lesion clip-thread method (o-ctm).In this method, a clip thread is attached to the healthy mucosa outside the circumferential incision line, and traction is applied to bring the scope and lesion into proximity for esd.Here, we assessed the efficacy of esd using the o-ctm compared to esd without the o-ctm.Methods: we retrospectively reviewed data from (b)(4) consecutive patients who underwent gastric esd for (b)(4) lesions located on the greater curvature of the u/m third of the stomach between (b)(6) 2015 and (b)(6) 2024.The primary outcome was the operation time, and secondary outcomes were resection speed, en bloc resection, r0 resection and complications in the o-ctm and without o-ctm esd groups.Results: of the (b)(4) included lesions, (b)(4) were resected without the o-ctm between (b)(6) 2015 and (b)(6) 2022 (without o-ctm group), and 26 lesions were resected using the o-ctm between (b)(6)2022 and (b)(6) 2024 (o-ctm group).The o-ctm group had significantly shorter operation times (40 min vs.77 min, p = 0.01) than the without o-ctm group.The resection speed was also significantly faster (20.1 mm2/ min vs.11.3 mm2/ min, p = 0.02).No significant differences in en bloc resection rate, r0 resection rate, and complications were observed.Conclusions: gastric esd using o-ctm is beneficial when compared with the esd without o-ctm in reducing operation time and improving resection speeds for treating lesions located on the greater curvature of the u/m region.Outcomes and definitions: post-esd bleeding was defined as obvious bleeding requiring endoscopic hemostasis or a decrease in the hemoglobin level of = 2 g/dl after esd.Perforation was defined as the presence of extraserosal tissue endoscopically visualized during the procedure.Type of adverse events/number of patients [o-ctm] post esd bleeding - (b)(4) patient.Perforation - (b)(4) patient.[without o-ctm] post esd bleeding - (b)(4) patient.Perforation - (b)(4) patients.
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 identifiers: (b)(6).
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: 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20495806
• Report Number: 9614641-2024-02008
• Device Sequence Number: 3519908
• Product Code: KNS
• UDI-Device Identifier: 04953170225963
• UDI-Public: 04953170225963
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092309
• 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): 12/05/2024

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: KD-611L
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/05/2024
• 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: D-201-11804.; GIF-Q260J OR GIF-H290T.; HX-610-090.; KD-441Q.; ORISE PROKNIFE BY BOSTON SCIENTIFIC.; VIO300D BY ERBE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown