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

Model Number	KD-655L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "spray coagulation reduces the use of hemostatic forceps for intraoperative bleeding in gastric endoscopic submucosal dissection." literature summary this study retrospectively assessed the effectiveness of spray modes on intraoperative bleeding during gastric endoscopic submucosal dissection (esd).A total of 316 bleeding events (156 in the swift group and 160 in the spray group) were consecutively recorded.In the swift group, hemostasis was performed using the swift mode with a retracted tip of the needle-type knife, followed by the hemostatic forceps.In the spray group, bleeding was treated in a stepwise manner: the swift mode, the spray mode, and the hemostatic forceps.The procedure time in the swift group and the spray group were 45 (34¿62) min and 46 (32.5¿61) min, respectively.There was no significant difference in the total hemostatic time (swift group, 20 s.; spray group, 16 s.; p = 0.42).In the esd outcomes of the swift group and the spray group, the en bloc resection rate (100% vs.100%), the r0 resection rate (100% vs.97%), and the rate of curative re section (86% vs.87%) had no significant differences.Discussion spray coagulation may also play a favorable role in decreasing the postoperative bleeding risk, considering three patients of bleeding in the swift group, whereas none in the spray group, although there was no significant difference of the bleeding rate and the number of patients were too small to discuss this matter.Furthermore, more patients in the spray group underwent pec with the dual knife only, but there was no difference in the postoperative bleeding rate compared with the swift group.This suggests that hemostatic forceps is not always necessary for pec.The prevention ability of the spray coagulation for the delayed bleeding would be worth investigating in a future prospective study.Type of adverse events/number of patients delayed bleeding - 3 patients.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to provide additional information received through follow up (b5).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.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• 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: 20272882
• Report Number: 9614641-2024-01872
• Device Sequence Number: 3531408
• Product Code: KNS
• UDI-Device Identifier: 04953170405624
• UDI-Public: 04953170405624
• 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): 10/18/2024

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-655L
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/18/2024
• 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: FD-410LR/UNKNOWN LOT NO.; GIF-2TQ260M/UNKNOWN SERIAL NO.; VIO 3 BY ERBE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown