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 Code	Perforation (2001)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature: ws1-7 treatment results and practice of esd for colorectal tumors with muscle layer traction findings.[literature summary]: [background] muscle layer traction findings during colorectal esd (muscle- if retracting sign; mr sign) is observed, incomplete resection or discontinuation is often required due to difficulty in removing the submucosal layer.This time, we report the treatment results of esd for mr sign-positive colorectal tumors, including the ingenuity of the procedure.Methods: of the large intestine esd performed in our department from january 2015 to december 2021, 36 cases (25 males, average age 68 years, average tumor diameter 43 mm, macroscopic type) were positive for intraoperative mr sign.The treatment results (esd completion rate, batch resection rate, ro resection rate, intraoperative perforation rate, delayed perforation rate) were examined for 0-ls in 18 cases, 0-isp in 12 cases, and 0-ila + ls in 6 cases.Recently, as a technique, when mr sign is diagnosed by preoperative eus, peeling is performed using the pocket-creation method, and an incision line is assumed for the muscular layer traction part, and the dual knife j is used carefully.A muscle layer incision is being performed.Results: in 28 cases (78%) with completed esd, 21 cases (58%) with batch resection, and 14 cases (39%) with ro resection, 10 cases (28%) had intraoperative perforation and 1 case (3) had delayed perforation.%) admitted.In 5 of the 10 cases of intraoperative perforation, esd was discontinued and surgical resection was performed (emergency 3 cases on the day, 2 cases at a later date), and the other 5 cases completed esd and were relieved by conservative treatment.One case of delayed perforation improved with conservative treatment.The final histopathological findings were adenoma in 4 cases, tis cancer in 8 cases, t1 cancer in 18 cases, and t2 cancer in 4 cases, and 2 cases were difficult to evaluate due to degeneration / dropout due to esd discontinuation.The treatment results of the recent 7 cases using the above procedure were esd completion in 7 cases (100%), batch resection in 7 cases (100%), ro resection in 5 cases (71%), and intraoperative perforation in 1 case (14%).), but it improved with conservative treatment.[conclusion] esd for mr sign-positive colorectal tumors could be resected collectively by preoperative eus and pocket-creation method.The actual esd video will be shown at the announcement.[type of adverse events / number of patients]: intraoperative perforation n = 10, delayed perforation n = 1.Kd-655q was selected as a representative product for dual knife j.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.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.Follow up to obtain additional information regarding the event was completed.New information added to b5 since the submission of the initial medwatch.Also, additional information added to b3, g2 and h6 since the submission of the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Follow up was completed to obtain additional details regarding the event.The following new information was received: the conservative treatments provided to the involved patients included administration of antibiotics, followed by fasting and administration of an unspecified intravenous drip.The reported complications were due to procedural factors and olympus equipment did not contribute.There was no malfunction of olympus equipment during the procedures.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15065748
• Report Number: 9614641-2022-00018
• Device Sequence Number: 11188882
• 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: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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-655Q
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown