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	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the literature titled "assessment of predictive factors associated with the technical difficulty of endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma: japanese multicenter retrospective study".Objectives: endoscopic submucosal dissection (esd) for superficial esophageal squamous cell carcinoma (escc) is performed for the treatment of lesions with varied backgrounds and factors.However, the predictive factors associated with the technical difficulty of esd remain unknown in patients with varied lesions.Therefore, this study aimed to identify the predictive factors associated with the technical difficulty of esd for escc using a retrospective cohort.Methods: this multicenter, retrospective study was conducted in 10 hospitals in japan.Consecutive patients who underwent esophageal esd between (b)(6) 2013 and (b)(6) 2019 were enrolled.Lesions of subepithelial tumors, adenocarcinoma, and adenoma were excluded.Difficult lesions were defined as esd requiring a long procedure time (>120 min), perforation development, piecemeal resection, or discontinued esd.In the present study, the clinical factors were assessed to identify the technical difficulty of esd using univariate and multivariate analyses.Results: among 1708 lesions treated with esophageal esd, eight subepithelial tumors, 44 adenocarcinomas, and two adenomas were excluded.Finally, 1505 patients with 1654 lesions were analyzed, and 217 patients with 217 lesions (13.1%) were classified as patients with difficult lesions.In multivariate analysis, the predictive factors associated with the technical difficulty of esd were as follows: tumors with varices, tumors with diverticulum, antiplatelet use (discontinued), circumference of tumor (>1/2), preoperative tumor size >30 mm, trainee, and nonhigh-volume center.Conclusion: this multicenter retrospective study identified the predictive factors associated with the technical difficulty of esd for escc with varied backgrounds and factors.Type of adverse events/number of patients: *perforation -32 *bleeding -7 one patient was bleeding during esd and six patients were bleeding after esd.", "bleeding was defined as a decrease in hemoglobin >2 g/dl, or requiring blood transfusion.".
Additional Manufacturer Narrative
The literature article is provided for additional information.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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 includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• 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: 19760025
• Report Number: 9614641-2024-01447
• Device Sequence Number: 9015989
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• 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: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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-612L
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown