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 Code	Aspiration Pneumonitis (4455)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "clinical results of proknife and dual knife usage examples in gastric esd".In this study, the purpose was to clarify the clinical results of gastric esd using proknife and single use electrosurgical knife kd-650.Of the 96 patients who underwent gastric esd at our hospital from january 2022 to september 2022, we retrospectively analyzed 57 patients using proknife as group p and 39 patients using single use electrosurgical knife kd-650 as group d.Intraoperative perforation was observed in 7% of group p and 0% of group d.Post-operative bleeding was observed in 5% of group p and 0% of group d.Aspiration pneumonia was observed in 0% of group p and 3% of group d.All cases could be treated with internal medicine treatment(treated medically).This literature article represents aspiration pneumonia observed in group d, single use electrosurgical knife kd-650.There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
Since the literature described "dualknife", we selected "single use electrosurgical knife kd-650" as a representative product.The product was unknown but a representative product was chosen for processing purposes.The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.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 and correction to the initial with information inadvertently left out (d8).Additionally, to provide additional information received through follow-up (b)(4).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.
Event or Problem Description
The author confirmed no olympus device malfunction during any procedure.No response provide by the author on if an olympus device cause or contribute to any of the patient adverse events.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18188612
• Report Number: 9614641-2023-01764
• Device Sequence Number: 12578878
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 11/30/2023
• 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: Other
• Patient Sex: Unknown