MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Esophagus (2399); Stenosis of the esophagus (4487); Unspecified Tissue Injury (4559)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus reviewed the following literature titled "outcomes of repeated endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma on endoscopic resection scar".Literature summary background: endoscopic submucosal dissection (esd) can be performed for superficial esophageal cancer.However, performing esd for superficial esophageal cancer on a previous endoscopic resection scar may be difficult.Methods: we compared the outcomes between esd for superficial esophageal cancers on previous endoscopic resection scar (group a) and that for naïve lesions (group b).The study included outcomes of esd, cumulative incidence of local failure, and predictors of the occurrence of local failure in esd patients with squamous cell carcinoma (scc).The outcome variables evaluated were en bloc resection rates, procedure times, adverse events, and overall survival rates.Results: overall, 220 lesions were extracted (groups a and b: 23 and 197 lesions, respectively).In groups a and b, the complete resection rates were 60.9 and 92.9% (p<0.001), and the mean procedure times were 79 and 68 min (p=0.15), respectively.The perforation rates in groups a and b were 4.3 and 1% (p=0.28).The1-year cumulative local failure rates were 22 and 1% (p<0.001), respectively.In the multivariate cox proportional hazards analysis, superficial esophageal scc on a previous endoscopic resection scar was a strong predictor of local failure (hazard ratio=21.95[3.99¿120.80], p<0.001).The3-year overall survival rates in groups a and b were 95 and 93% (p=0.99), respectively.Conclusions: repeated esd on scar is an option for treating superficial esophageal scc with an acceptable rate of adverse events.Because of the low complete resection rate and high local failure compared with conventional esd, strict endoscopic follow-up is required after repeated esophageal esd.Type of adverse events/number of patients muscle injury (45 cases) perforation (3 cases) stricture (6 cases) perforation was defined as an event in which mediastinal connective tissue was observed during the procedure.All perforations could be closed endoscopically.Esophageal stricture was defined as the inability of a standard upper gi endoscope to pass through a treatment site.All esophageal strictures were corrected by subsequent endoscopic dilatation.The event date was reported as the publication date of the literature.
Additional Manufacturer Narrative
This report is related to the following linked patient identifier: (b)(6).The device was not returned.Attempts were performed to obtain additional information, but no response was received.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 and to provide additional information received from the author (b5).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.Therefore, the root cause cannot be determined.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The following additional information was received from the author: an olympus device did not cause or contribute to the adverse event described in the article.Also, it was confirmed that an olympus device malfunction did not occur.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• 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: 20224176
• Report Number: 9614641-2024-01832
• Device Sequence Number: 7494557
• Product Code: KNS
• UDI-Device Identifier: 04953170453977
• UDI-Public: 04953170453977
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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-650L
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GIF-Q260J EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown