MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number	KD-645L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Bowel Perforation (2668)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the literature titled, "endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial" the purpose of this retrospective study was to directly compare endoscopic submucosal dissection (esd) and endoscopic full-thickness resection (eftr) for the resection of challenging colorectal lesions in a randomized trial.90 consecutive patients were included in the study, equally representing the 3 challenging lesion types.Subgroup analysis according to lesion type: 1.Lst-ng group.A.Eftr group.I.2 patients presented with late bleeding and were treated conservatively.B.Esd group.I.A single recurrence was found and managed successfully with eftr.2.Nonlifting group.A.Eftr group.I.2 patients presented with local recurrence; both were treated with standard polypectomy.B.Esd group.I.2 patients had a perforation during the procedure and were treated conservatively.3.Adenoma relapse/recurrence group.A.Eftr group.B.Esd group.I.1 patient had a perforation and was treated conservatively.This medwatch report is related to the following patient identifiers: (b)(6) : cf-h180dl; (b)(6) : gif-h290t; (b)(6) : kd-655q.This complaint represents patient identifier (b)(6) , model kd-645l.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus for evaluation.The investigation is in process.The literature described "cf-h180dl" and "gif-q180".Both are evis exera ii series; therefore, "cf-h180dl" was selected as the representative device.The literature described "dual-knife and tt-knife (olympus)"; therefore, "kd-655q" and "kd-645l" were selected as representative devices.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.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.This supplemental report included additional information received from the author.B5 updated accordingly.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 events described in the article.Also, no olympus device malfunction occurred during any of the events.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• 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: 18526619
• Report Number: 9614641-2024-00117
• Device Sequence Number: 18074359
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182408
• 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): 01/31/2024

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-645L
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 01/31/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CF-H180DL.; GIF-H290T.; KD-655Q.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown