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

Model Number	KD-610L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Kd-610l, kd-611l, or kd-612 were used for the procedures in the literature.One complaint is created as kd-611l with the largest number of units shipped from 2008 to 2022 (periods are referenced from table 1 of the literature).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 the results.
Event or Problem Description
Objectives: limited information is available on the efficacy and safety of endoscopic resection (er) of gastric submucosal tumors (smts) in japanese endoscopic practice where er for gastric tumors is extremely popular.Methods: we conducted this study to elucidate the current scenario of er for gastric smts in japanese endoscopic practice.Patients (from 12 institutions) with gastric smts who underwent er were enrolled from the first case until august 2020.Results: we enrolled 117 patients with 118 lesions.The number of patients who underwent er increased over the years.The mean endoscopic tumor size was 20±7.2 (8¿40)mm.The growth type was primarily intraluminal (90%).The mean resection and wound closure times were 58±38 (range, 12¿254) min and 31±41 (range, 3¿330)min, respectively.Complete er was achieved for 117 (99%) lesions.Full-thickness resection rate was 44%; however, only 12 (10%) patients required abdominal paracentesis for decompression.Endoscopic treatments were completed in 115 (97%) lesions, while three lesions required conversions to laparoscopic surgery due to luminal collapse, uncontrolled bleeding, and difficulty in defect closure.Gastrointestinal stromal tumors were the most common pathology (74%).No recurrence was observed during the mean follow-up period of 4.3±2.9years.The 5-year overall survival rate was 98.9% (95% confidence interval 97.8¿100%).Conclusion: performance of er for gastric smts is increasing in japan.The technique seems feasible in japanese endoscopic practice, warranting further validation in a prospective study.Type of adverse events/number of patient: delayed bleeding n=2.This literature article requires 3 reports.The related patient identifiers are as follows: 1.(b)(6)/ kd-611l.2.(b)(6)/ kd-610l.3.(b)(6)/ kd-612l.This medwatch report is for patient identifier (b)(6).There is no report of any olympus device malfunction in any procedure described in this study.
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, the relationship between the device and the adverse events cannot be confirmed.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: 16616250
• Report Number: 9614641-2023-00428
• Device Sequence Number: 6272418
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• 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: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: KD-610L
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/03/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown