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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "dual knife j" as olympus device used in e (esd) group where adverse events occurred, we selected "kd-655l" as a representative product.The product was unknown but a representative product was chosen for processing purposes.The device was not returned to olympus for evaluation.The investigation is in process.The literature article is attached for additional information.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
Event or Problem Description
Olympus reviewed the following literature titled "treatment results at our hospital at the time of introduction of endoscopic treatment for superficial non-papillary duodenal tumors." background: endoscopic treatment for superficial non-papillary duodenal tumors (snadet) requires high technical skills due to poor operability and thin muscle layers.In addition, it is important to take measures against post-bleeding and delayed perforation due to pancreatic juice and bile exposure.Methods: at our hospital, we started submucosal dissection (esd) under general anesthesia for snadet from (b)(6) 2022, and endoscopic mucosal resection under immersion (uemr) under sedation with midazolam from (b)(6) of the same year.Up to (b)(6) 2023, six patients with esd were in group e and five patients who underwent uemr were in group u, and the treatment outcomes at the time of endoscopic treatment induction of snadet were retrospectively examined.One patient in group e underwent sedation with propofol because the lesion was localized near the pylorus ring, and one patient in group u was excluded from pathological analysis because the specimen could not be retrieved.Endoscopic procedure: esd was basically performed with a dual knife j without a traction device, and uemr used the snare master.Regarding wound closure, esd ball lesions were treated with a polyglycolic acid sheet, lesions deeper than the descending part were treated with over-the-scope clips and hemostatic clips, and uemr was performed with only hemostatic clips.Regarding adverse events, there were no cases of intraoperative/delayed perforation in either group.In one case in group e (a bulbar lesion performed under general anesthesia), post-bleeding was observed on the first postoperative day, but endoscopic hemostasis was performed, and blood transfusion was not required.Conclusion: the treatment results of esd and uemr for snadet at our hospital were good, and perforation and post-bleeding could be safely treated by appropriate wound treatment.This literature article requires 1 report.Type of adverse events and number of patients.Post-bleeding (n=1).There is no report of any olympus device malfunction in any procedure described in this study.
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-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: 17730875
• Report Number: 9614641-2023-01308
• Device Sequence Number: 6134925
• 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): 09/15/2023

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-655L
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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