MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-612 1

Model Number	KD-612L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Emphysema (1832); Pleural Effusion (2010); Perforation of Esophagus (2399)
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "a case of conservative treatment for a large perforation during esophageal esd with suspected partial esophageal strictures".The literature reported the result of a patient with early-stage esophageal cancer who underwent endoscopic submucosal dissection (esd) procedure using olympus dual knife j and it knife nano.In the literature, the following perforation have been reported to have occurred."after marking the periphery of the lesion with a dual knife j, the dissection was started from the mouth side.During the dissection, the endo track was used for traction, but suddenly a huge loss of muscle layer and fibrous structures were observed.The perforation was sutured using clips and indwelling snares, and the perforation was filled with pga sheet and fibrin glue.A ct scan after the procedure showed mediastinal emphysema around the perforation and across the diaphragm.On the next day, the mediastinal emphysema worsened and subcutaneous emphysema of the anterior chest and right pleural effusion appeared, and the inflammatory response increased with wbc 13800 and crp 17.Lmg/dl.After discussion with the surgeon, it was decided to continue conservative treatment because the patient's general condition was stable.Fasting, central venous feeding, and antibiotics were administered, and the inflammatory response gradually decreased.However, gastrography under a fine endoscope performed on the seventh day of the disease showed that the perforation remained and contrast medium leaked out of the esophageal wall from the same site.Since surgical closure of the foramen magnum was invasive and high-risk, fasting was continued, and fibrin glue was reinjected into the foramen magnum on the 12th day.On the 16th day, the foramen magnum was filled with white substance and no leakage of contrast medium was observed.The patient resumed eating on the 17th day and was discharged home on the 26th day." based on the available information, specific information on the subject device and the patients were not provided.There is no description of the device's malfunction.However, omsc assumes that "perforation" might be related to the subject device, and the subject device might be caused or contributed to a death or serious injury.Therefore, omsc determined that the "perforation" was adverse event to submit.Omsc will submit a medical device report (mdr) depending on the event.
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the serial number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.In the literature, there is no description of the device's malfunction.
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 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.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-612 1
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13057646
• Report Number: 8010047-2021-16575
• Device Sequence Number: 19247873
• Product Code: KNS
• UDI-Device Identifier: 04953170325892
• UDI-Public: 04953170325892
• 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: Other,Foreign,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 11/25/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 04/20/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male