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)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled"symposium 7 (japanese society of gastroenterological endoscopy / japanese society of gastroenterology)".Literature summary: purpose with the progress of high-frequency devices, effective hemostasis can be achieved by applying electricity to the tip of the knife during gastric esd surgery, and there are also many cases where hemostatic forceps are not required.On the other hand, the use of hemostatic forceps to coagulate blood vessels as a means of preventing post-gastric esd bleeding is recommended in the esd/emr guidelines.In this context, it is not clear whether to use hemostatic forceps as a means of preventing post-operative bleeding in cases where hemostatic forceps are not required during surgery, or whether it is sufficient to prevent bleeding using the tip of the knife, so we conducted a retrospective study.[methods] patients who underwent gastric esd using the dualknife j (olympus) at our hospital from (b)(6) 2020 to (b)(6) 2024 were included in the analysis.If haemostatic forceps were used during the procedure, it was assumed that the prevention of bleeding was carried out using the haemostatic forceps (group f).On the other hand, if the esd was completed using only the dualknife j, it was assumed that the prevention of bleeding was carried out using the tip of the knife (group k).The settings of the radiofrequency device used for haemostasis were not specified.Postoperative hematemesis or melena requiring additional endoscopic examination was defined as post-procedural bleeding.Results: the study included (b)(4) patients with (b)(4) lesions, with a mean age of 71 years.(b)(4) were taking antithrombotic drugs, and the mean tumour diameter was 20.5 mm.Postoperative bleeding occurred in (b)(4), including (b)(4) patients in group f and (b)(4) patients in group k.The results of univariate analysis of the rate of post-hemorrhage were as follows: age ((b)(4), l-region lesion ((b)(4), tumor diameter ((b)(4), those taking antithrombotic agents ((b)(4)), and the duration of surgery(b)(4) were significantly associated with a higher rate of postoperative hemorrhage.On the other hand, there was no significant difference in the rate of post-procedural bleeding between group k and group f, with an odds ratio of (b)(4)).After performing a multivariate analysis of the items that showed a significant difference in the univariate analysis, the results showed that there was a significant difference in the l-region lesion ((b)(4)), tumour diameter (b)(4), and those taking antithrombotic agents ((b)(4) were all found to be significant.[conclusion] it was shown that the independent factors for post-bleeding after gastric esd were the l-region, tumour diameter, and the use of antithrombotic drugs.There was no significant difference in the rate of post-bleeding between the knife tip and hemostatic forceps.Type of adverse events/number of patients.Post-operative bleeding (b)(4).
Additional Manufacturer Narrative
Attempts were performed to obtain additional information, but no response was received.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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 from the author (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 reported event was likely an accident, or a complication associated with a surgical procedure while using the subject device.There was no complaint reported on the subject device and 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: 20676901
• Report Number: 9614641-2024-02087
• Device Sequence Number: 20909162
• 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): 01/03/2025

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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown