MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number	KD-V441M
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	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "efficacy analysis of endoscopic submucosal dissection for the early gastric cancer and precancerous lesions." endoscopic treatment of precancerous lesions and early gastric cancer has been widely accepted in recent years.Endoscopic submucosal dissection (esd), following established indication criteria, can lead to cure of the disease in more than 90% of cases.Objective ¿ this study aimed to analyze the use of esd in patients with early gastric cancer and precancerous lesions, as well as the results of the procedure, its complications and effectiveness in controlling the disease.Methods ¿ this is a retrospective cohort study composed of 41 patients aged from 53 to 87 years (mean age: 65 years; 58.53% male) who were analyzed from 2008 to 2019.The variables collected from the medical records were: comorbidities, classification of the lesion regarding resection criteria, type of resection, histology, degree of invasion, resection margin, complications, disease recurrence.Statistical analysis was performed using the kruskal-wallis test, the mcnemar¿s test, and the mann-whitney test, with 5% statistical significance (p<0.05).Results ¿ the most frequent site of the lesion was the gastric antrum and the predominant presentation by the japanese or paris classification was the one with depressed components in 56.09%.Adenocarcinoma occurred in 75.6% of the biopsies, and the remainder were adenomas without neoplasia.En-bloc resection occurred in 97.57% of cases, and compromise of the safety margin occurred in one patient.The main pre-existing comorbidity was liver cirrhosis in 29.26% of cases.There was a significant increase in post- esd adenocarcinoma compared to pre-resection diagnosis.The mean follow-up time was 38.4 months, with one recurrence (2.43%) and two metachronous lesions (4.87%).Complications during and after the procedure occurred in three patients (7.31%), being due to bleeding (two cases) and perforation (one case).There was one death due to a cardiac event not directly related to the procedure.Conclusion ¿ endoscopic submucosal dissection proved to be a safe procedure, with a low complication and recurrence rate.Its recommendation must occur within the established criteria; however, it can be indicated for patients outside the criteria, if there is a high risk for surgical treatment.Type of adverse events/number of patients: bleeding: 2 patients.Perforation: 1 patient.Death: 1 patient.The authors report the death was unrelated to the procedure and was determined to be not reportable.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6): wb991046; (b)(6): kd-611l; (b)(6): kd-v441m.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
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.
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 event 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.This supplemental report includes information added to e4.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Common Device Name: SINGLE USE 3-LUMEN NEEDLE 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: 15807345
• Report Number: 9614641-2022-00629
• Device Sequence Number: 14889795
• Product Code: KNS
• UDI-Device Identifier: 04953170244124
• UDI-Public: 04953170244124
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K955247
• 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): 12/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: KD-V441M
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/01/2022
• 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: NON- OLYMPUS, FLUSH KNIFE, SN UNKNOWN; NON- OLYMPUS, TRANSPARENT TIP HOOD, SN UNKNOWN; OLYMPUS, KD-611L, LOT UNKNOWN; OLYMPUS, WB991046, SN UNKNOWN
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown