MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650L
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	12/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "usefulness of the clip-and-snare method using the pre-looping technique for endoscopic submucosal dissection of gastric neoplasia: a randomized controlled trial".This multicenter, randomized controlled trial aimed to assess the efficacy of clip-and-snare method using the pre-looping technique (csm-plt) in gastric endoscopic submucosal dissection (esd).A total of 378 patients were finally included in the per-protocol analysis.The mean procedure times were 69.7 and 58.0 min for the conventional esd and csm-plt groups, indicating that the procedure was significantly shorter in the csm-plt group (p=0.009).The r0 resection rate tended to be higher in the csm plt group than in the conventional esd group (p=0.09).The mean procedure time was significantly shorter in the novice (p=0.04), tumor size =20 mm (p=0.02), and it knife (p=0.045) groups.The mean preparation time for csm-plt was 2.3 min.Csm-plt method shortened the esd procedure time.Moreover, csm-plt is safe, does not increase complication rates, and is associated with better r0 resection rates than conventional esd.Type of adverse events/number of patients.Perforation - 5.Delayed bleeding - 17.This literature article requires 10 reports.The related patient identifiers are as follows: 1.(b)(6) /d-201-11804.2.(b)(6) /kd-611l.3.(b)(6) /kd-650l.4.(b)(6) /kd-620lr.5.(b)(6) /kd-1l-1.6.(b)(6) /kd-630l.7.(b)(6) /fd-410lr.8.(b)(6) /sd-221u-25.9.(b)(6) /hx-610-090.10.(b)(6) /gif-q260j.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 literature article is attached for additional information.The device history record was unable to be reviewed for this device since no product malfunction was reported.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 the reported event is an accident, or a complication associated with a surgical procedure using the subject device.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• 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: 16917915
• Report Number: 9614641-2023-00652
• Device Sequence Number: 12495237
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

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-650L
• 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: 04/17/2023
• Initial Report FDA Received Date: 05/12/2023
• 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: Required Intervention; Other
• Patient Sex: Unknown