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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature received a literature titled "o083 results of esd treatment of duodenal epithelial tumors."     literature summary although the usefulness of underwater esd (u-esd), wound closure, and enbpd in preventing perforation has been reported, esd for duodenal tumors is challenging and associated with many complications.We will retrospectively review the outcomes of esd for duodenal epithelial tumors at our institution.  patient background: age 53-81 years, male to female ratio 5:1, preoperative biopsy in 4 cases, venous anesthesia 3:3, descending leg in 5 cases, horizontal leg in 1 case, tumor length 16-65 mm, and fibrosis in 1 case.Devices used were dualknifej 2.Omm in 3 cases, proknife2.Omm in 3 cases, precuttingknife in 1 case, and hookknifej in 2 cases.Traction was used in one case with indwelling snare + dental floss lateral traction and in one case with clip lesion contralateral traction.Wound closure was performed in 4 cases, and enbpd was placed in 1 case for cholangiopancreatic stenting to prevent cholangitispancreatitis and in 2 cases of difficult wound closure, and no pancreatitis was observed after ercp.Resection time ranged from 59-300 minutes (mean 141 minutes).4 patients underwent second look, 1 with hemostasis and 2 with additional wound clips.Pathology was negative for adenoma in all cases   type of adverse events/number of patients: event1: perforation (1 case) event2: postoperative bleeding (1 case).The report is linked to the related patient identifier (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 from the author.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: 18664473
• Report Number: 9614641-2024-00313
• Device Sequence Number: 8240241
• 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: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 02/20/2024
• 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: SNGLE USE ELECTROSURGICAL KNIFE KD-625LR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown