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); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Health effect - clinical code 4581 is used to code for esophageal stricture.The suspect device has not been returned to olympus.Additional information has been requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "endoscopic resection of residual or recurrent lesions after circumferential radiofrequency ablation for flat superficial esophageal squamous cell neoplasias." summary: we report the efficacy and safety of endoscopic resection of residual/recurrent superficial esophageal squamous cell neoplasias (sescns) after circumferential radiofrequency ablation (rfa).Sescn patients treated with primary endoscopic submucosal dissection (esd) served as a control group.Endoscopic mucosal resection failed to remove one residual sescn.The pathological results of the 16 resected specimens were classified into three groups: high-grade intraepithelial neoplasia (hgin) without ductal/submucosal glandular involvement (37.5%), hgin with ductal/submucosal glandular involvement (25.0%), and cancer with muscularis mucosae or deeper involvement (37.5%).These three groups may imply three possible routes in which residual/recurrent sescns occurred.Compared with the control group, the study group had similar procedural speed, en bloc resection rate, r0 resection rate, and complication rate.In conclusion, the safety and efficacy of post-rfa esd were similar to those of primary esd.We recommend that esd should be the treatment of choice for residual/recurrent sescns after initial rfa.Type of adverse events/number of patients : event1: delayed bleeding (defined as requiring endoscopic hemostasis) - 1 patient.Event2: esophageal stricture (defined as requiring endoscopic dilations) - 23 patients.Event3: esophageal stricture - 1 patient.This literature article requires 3 reports.The related patient identifiers are as follows: (b)(6)- kd-655l for events 1 and 2.(b)(6)- kd-612l for events 1 and 2.(b)(6)- kd-1l-1 for event 3.This medwatch report is for (b)(6).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 events cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.In addition, the malfunction of the device has not been reported, and from clinical/medical evaluation and risk assessment, it is possible that the reported event is an accident, or a complication associated with a procedure using the subject device.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information as reflected on b5.Please also see update to h6 - type of investigation to reflect that the device has not been returned.
Event or Problem Description
Additional information was received from the author, who confirmed that the adverse events were not caused by an olympus device and that there was no malfunction of any olympus 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: 17484752
• Report Number: 9614641-2023-01120
• Device Sequence Number: 7826490
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 08/25/2023

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-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: Not provided
• Supplement Date Received by Manufacturer: 08/13/2023; 08/18/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/17/2023; 08/25/2023
• 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