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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "efficacy and safety of clearcut¿ knife h-type in endoscopic submucosal dissection for gastric neoplasms: a multicenter, randomized trial." literature summary: this randomized, controlled trial aimed to evaluate the efficacy and safety of the clearcut¿ knife h-type, which is an integrated needle-tipped and insulated-tipped (it) knife.A total of (b)(6) patients (50 in the h-knife group and 48 in the it-knife group) were analyzed.The median total procedure time was 11.9 minutes (range, 4.4¿47.2 minutes) in the h-knife group and 12.7 minutes (range, 5.2¿137.7 minutes) in the it-knife group (p=0.209).The complete resection rates in the h-knife and it-knife groups were (b)(4) and (b)(4), respectively (p>(b)(4)).The curative resection rate was lower in the h-knife group than in the it-knife group ((b)(4) vs.(b)(4), p=(b)(4)).The overall adverse event rates were not significantly different between the 2 groups (p=(b)(4)).The newly developed hybrid device, the clearcut¿ knife h-type, had comparable efficacy to the conventional it knife for gastric esd.Type of adverse events/number of patients.Gif-q260j, gif-hq290: *early delayed bleeding (4) , *microperforation (2) , itknife2, dual knife: *early delayed bleeding(4).Microperforation was defined as minimal free air on chest radiography without symptoms or signs of peritonitis.Microperforation occurred in 2 patients ((b)(4)) in the h-knife group.The patients with microperforations were treated conservatively without additional interventions.Early delayed bleeding was confirmed in 4 patients in the it-knife group ((b)(4)) and required additional hemostasis and an extension to the hospitalization period.There is no report of any olympus device malfunction in any procedure described in this study.This literature requires 4 reports.The related patient identifiers are as follows: -(b)(6) :gif-q260j.-(b)(6) :gif-hq290.-(b)(6) :kd-611l.-(b)(6) :kd-650l.This report is for (b)(6).
Additional Manufacturer Narrative
The event date was reported as the publication date of the literature.The literature article is attached for additional information.The literature described "dual knife", olympus selected "kd-650l" as a representative product.The product was unknown, but a representative product was chosen for reporting purposes.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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.Olympus will continue to monitor field performance for this device.

• 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: 17843307
• Report Number: 9614641-2023-01424
• Device Sequence Number: 17243679
• Product Code: KNS
• UDI-Device Identifier: 04953170453977
• UDI-Public: 04953170453977
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 10/24/2023

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: 09/20/2023
• Supplement Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/24/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown