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

Model Number	KD-610L
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	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is related to the following linked patient identifiers: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
Olympus reviewed the following literature titled "free-hand endoscopic full-thickness resection for duodenal subepithelial lesions." literature summary: background and aim: this work aims to evaluate the efficacy and safety of free-hand endoscopic full-thickness resection (eftr) for duodenal subepithelial lesions (sels).Methods: we performed a retrospective review of 105 patients with duodenal sels who underwent free-hand eftr.Free-hand eftr means no other devices (over-the-scope clip or full-thickness resection device) are required.The preoperative baseline data, procedure-related characteristics, and postoperative outcomes were analyzed.Results: the technical success rate was 99.0%, and the en bloc resection rate was 94.2%.A total of nine (8.7%) patients experienced major postoperative adverse events (aes).The incidence of major aes was significantly higher for lesions with a maximum diameter =2cm (30.4%) than for lesions with a maximum diameter <2cm (2.6%) (p<0.001).There were also significant differences in the incidence of major aes for peri-ampullary lesions (37.5%), bulb lesions (4.8%), bulb-descending junction lesions (6.7%), and descending part lesions (12.5%) (p=0.032).Multivariable regression analyses revealed that the maximum diameter =2cm (or=18.108; 95% ci=1.881¿174.281; p=0.012) and lesions located in peri-ampullary (or=18.950; 95% ci=1.219¿294.648; p=0.036) were independent risk factors for major aes.The mean duration of the follow-up period was 36.6±21.3months, and only one patient with gastrointestinal stromal tumors recurred.Conclusions: free-hand eftr is a safe and effective technique for non-ampullary duodenal sels with a maximum diameter of <2cm.Given the complexity of the duodenal anatomy, this procedure should be performed by experienced endoscopists.Type of adverse events/number of patients: one 63-year-old female experienced an adverse event of delayed bleeding after the eftr procedure.The patient received treatment of endoscopic hemostasis.There was no allegation of device malfunction identified in the article.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: h6.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22127675
• Report Number: 9614641-2025-00882
• Device Sequence Number: 12633398
• Product Code: KNS
• UDI-Device Identifier: 04953170208546
• UDI-Public: 04953170208546
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

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-610L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/13/2025
• 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 Age: 63 YR
• Patient Sex: Female