MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655Q
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Stenosis (2263)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event date was reported as the publication date of the literature.The following procedure and devices are used in this literature.Dual knife j : we assumed that this model is kd-655q.Esd knife or hemostatic forceps (coagrasper fd- 410 lr) the literature article is attached for reference.This device has not been returned for evaluation.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, "high proficiency of esophageal endoscopic submucosal dissection (esd) with a "tunnel clip traction" strategy: a large french multicentric study".Literature summary: this study aimed to assess the technical results and outcomes of a "tunnel clip" strategy for esophageal esd procedures performed by less experienced operators for the treatment of superficial neoplasms.A total 195 esophageal esd procedures performed.The percentage of resected esophageal circumference in superficial squamous cell carcinomas (ssc) tended to be higher than that in high-grade dysplasia (hgd)/adenocarcinoma (adk) complicating barrett¿s esophagus (be).The en bloc, r0 and curative resection rates were both higher in hgd/adk complicating be than in sscs.No significant difference was found in terms of r0 resection, rate of performing the procedure, or perforation according to the location of the lesion (upper third, middle third, lower third, esophagogastric junction).The ¿tunnel+clip¿ strategy is safe, and allows to achieve high en bloc, r0 and curative resection rates.Type of adverse events/number of patients event1: perforation - 1 patient ( treated endoscopically with 4 clips and intravenous antibiotics.Event2: postprocedural bleeding - 7 patients (managed endoscopically) postprocedural bleeding was recorded if it triggered an emergency consultation or hospitalization.Event3: stenosis - 31 patients (managed by endoscopic hydraulic dilation.Patient identifiers: (b)(6) - dual knife used in the procedure.(b)(6) - hemostatic forceps used in the procedure.This report is for (b)(6).
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-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: 17168091
• Report Number: 9614641-2023-00875
• Device Sequence Number: 7154544
• Product Code: KNS
• UDI-Device Identifier: 04953170405631
• UDI-Public: 04953170405631
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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-655Q
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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: Required Intervention
• Patient Sex: Unknown