MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-612

Model Number	KD-612L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described it knife nano, olympus selected "kd-612l" as a representative product.This device was not returned for evaluation.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled, "outcome of esophageal esd training using it knife nano".A safe and efficient resection method is required to equalize esophageal endoscopic submucosal dissection (esd) procedures.We have been performing esophageal esd using it knife nano and a clip with thread in our hospital, and we investigated the safety and efficiency of this method in beginners.We compared the outcomes of 8 novice surgeons who performed more than 15 esophageal esd procedures between 2013 and 2022 with those of experienced surgeons.Changes in dissection speed before and after training were examined using the first 7 cases and the last 7 cases.Type of adverse events/number of patients 1.Perforation rate was 2.5% vs 1.2% 2.Postoperative bleeding rate was 0.7% vs.1.3% there is no report of any olympus device malfunction in procedure described in the study.
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.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.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Olympus further received information from the author that the event was not caused by an olympus device and there was no malfunction observed.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information from the author.Updated field: b5.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612
• 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: 17292354
• Report Number: 9614641-2023-00960
• Device Sequence Number: 11811038
• Product Code: KNS
• UDI-Device Identifier: 04953170453922
• UDI-Public: 04953170453922
• 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,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2023

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-612L
• Device Catalogue Number: N4468940
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 07/27/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 07/26/2023; 08/08/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown