MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Bowel Perforation (2668)
Date of Event	08/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "clinical outcomes of endoscopic submucosal dissection for large pedunculated colorectal carcinoma: a retrospective multicenter study" complete en-bloc resection of pedunculated colorectal carcinoma is necessary for a proper pathological diagnosis.However, due to poor visibility, large pedunculated colorectal carcinomas are difficult to snare and resect en-bloc using endoscopic resection or polypectomy.Additionally, the bleeding risk of large pedunculated colorectal carcinomas is relatively high.We aimed to assess the feasibility and safety of endoscopic submucosal dissection for large pedunculated colorectal carcinomas.We conducted a retrospective multicenter cohort study to assess 36 consecutive patients with 36 large pedunculated colorectal carcinomas who underwent endoscopic submucosal dissection and evaluated the outcomes of endoscopic submucosal dissection.Furthermore, patients were divided into two groups according to the procedure time, and the factors related to the procedure time were assessed.Four patients experienced severe bleeding and was controlled endoscopically in all patients.Severe bleeding was defined as bleeding that required multiple coagulation (= 10 times) during the procedure.Delayed perforations occurred in one patient that required surgery.A long procedure time was correlated with the location of the flexure and poor endoscope operability.There is no report of any olympus device malfunction in any procedure described in this study.Type of adverse events/number of patients: event1: severe bleeding - 4 patients.Event2: delayed perforation -1 patient.This literature article requires 3 reports.The related patient identifiers are as follows: (1) kd-650q (dual knife): (b)(6).(2) kd-655q (dual knife j): (b)(6).(3) kd-612q (it knife nano): (b)(6).This medwatch report is for patient identifier (b)(6).
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.Doi: 10.1002/deo2.277.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 17818753
• Report Number: 9614641-2023-01404
• Device Sequence Number: 2302579
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171158
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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-655Q
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/17/2023
• 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
• Patient Sex: Unknown