MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number	KD-650U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 25, olympus medical systems corp.(omsc) received the literature "insulated-tip knife tunneling and c-shaped incision for esophageal endoscopic submucosal dissection: an initial western experience¿.The purpose of the literature was to investigate the feasibility and safety of it-knife tunneling and c-shaped incision esophageal esd in the (b)(6).All esd procedures were performed with an olympus (b)(4) upper endoscope (olympus) fitted with a disposable straight soft distal attachment ((b)(4); olympus).If submucosal fibrosis was encountered, esd technique would be converted to dualknife (b)(4); olympus) dissection for the fibrotic areas.A dualknife was used for making cautery markings around the lesion and an it-knife nano ((b)(4); olympus) was used for submucosal dissection.Blood vessel coagulation was performed with a coagrasper hemostatic forceps (b)(4); olympus).An electrosurgical generator and an injection needle were used, but the devices were non-olympus devices.In the literature, it was reported one case of an intraprocedural bleeding requiring one unit of packed red blood cells and one case of a delayed bleeding requiring emergency endoscopy.There is no more information about one case of an intraprocedural bleeding requiring one unit of packed red blood cells.The literature wrote, ¿there was one case with delayed bleeding requiring emergency endoscopy.This patient was a cirrhotic who did not require a blood transfusion but repeat endoscopy noted a bleeding submucosal vessel that was coagulated.¿ based on the available information, a direct relationship between the olympus product and these complications could not be determined.However, one case of an intraprocedural bleeding requiring one unit of packed red blood cells and one case of a delayed bleeding requiring emergency endoscopy might be serious injury, and the olympus knife might be used when the cases occurred.This is the report regarding one case of an intraprocedural bleeding requiring one unit of packed red blood cells.
Additional Manufacturer Narrative
The subject device was not returned to olympus.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot 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 was 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-650
• 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: 12873097
• Report Number: 8010047-2021-15061
• Device Sequence Number: 4623146
• Product Code: KNS
• UDI-Device Identifier: 04953170265785
• UDI-Public: 04953170265785
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: 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-650U
• 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: 10/26/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 11/25/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown