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 Code	Gastrointestinal Hemorrhage (4476)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "efficacy and safety of mc-003 solution for endoscopic mucosal or submucosal resection: a prospective, multicenter, randomized, triple-blinded, parallel-group, phase iii study." background and aims: the safety and efficacy of solutions for submucosal injection are critical for endoscopic resection of gastric adenomas or early gastric cancers.Although several injectable solutions have been introduced for endoscopic resection, they have some limitations.We aimed to compare the efficacy of the new sodium alginate¿based solution mc-003 with that of normal saline (ns; 0.9% sodium chloride).Methods: in this randomized, triple-blind study, 70 patients were initially enrolled for emr or endoscopic submucosal dissection (esd).The main outcomes included the need for additional injections, completion of en bloc resection, and occurrence of adverse events.Results: each group ultimately included 34 patients.Complete en bloc resections were achieved in all patients (p z 1.000).The mc-003 group had more peri-neoplasm tissue fibrosis (p z.056) and needed fewer additional injections for lesions >15 mm (p z.037), located in the distal portion of the stomach (p z.007), and during esd procedures (p z.001).The adverse event rate was comparable in both groups.It is serious according to following description.In terms of severe adverse events, one case of delayed hospital discharge due to moderate to severe gi bleeding occurred only in the ns group (1 [2.9%] of 34 cases).Conclusions: mc-003 outperformed ns in reducing the need for additional injections during en bloc resection, particularly in larger lesions located in the distal portion of the stomach (where most lesions were found) during esd procedures, without increasing the incidence of serious adverse events.Mc-003 is a promising submucosal injectable solution in real-world clinical settings.(gastrointest endosc 2024;100:36-45.) type of adverse events (ae)/number of patients: moderate-severe gastric bleeding (1).
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.This report is related to linked to the following patient identifiers: (b)(6).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.Additional information requested from author; however, all requested information is unknown.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: 20042245
• Report Number: 9614641-2024-01688
• Device Sequence Number: 20825968
• Product Code: KNS
• UDI-Device Identifier: 04953170225963
• UDI-Public: 04953170225963
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/06/2024

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: 07/24/2024
• Supplement Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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-201-10704, LOT UNKNOWN.; KD-620LR, LOT UNKNOWN.; KD-655L, LOT UNKNOWN.; NM-600L-0423, LOT UNKNOWN.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown