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	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a literature titled "comparison between endoscopic submucosal tunnel dissection and endoscopic submucosal dissection for superficial neoplasia at esophagogastric junction: a case-matched controlled study of a single center from china." this study aimed to investigate the difference of endoscopic submucosal dissection (esd) and endoscopic submucosal tunnel dissection (estd) in treatment outcomes and complications through the comparison of patients with esd or estd.Compared with esd group, estd group got shorter resection time (111.00±11.70 min for esd group vs.71.59±6.18 min for estd group, p=0.008) and faster section speed (0.23±0.03 cm2/min for esd group vs.0.37±0.06 cm2/min for estd group, p=0.012).No complication was found to occur in estd group, while 1 patient with mp damage and one with delayed bleeding was found in esd group.This study concludes that the estd was safer and more effective and reliable endoscopic technique compared with esd.Types of adverse events/number of patients: [esd group].One patient with mp damage (mucosal plane).One patient with delayed bleeding.This is four of four reports.The following are the related complaints: (b)(6)- d-201-11804.(b)(6)- fd-410lr.(b)(6)- gif-q260j.(b)(6)- kd-650l.
Additional Manufacturer Narrative
No device was returned to olympus for evaluation.No lot number or serial number was provided for the devices involved.The exact cause of the patients¿ outcome cannot be conclusively determined.Olympus contacted the author of the article to obtain more information regarding the reported adverse events.A supplemental report will be submitted when new and relevant information is received.
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 event 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.

• 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: 16039936
• Report Number: 9614641-2022-00851
• Device Sequence Number: 15007268
• Product Code: KNS
• UDI-Device Identifier: 04953170265761
• UDI-Public: 04953170265761
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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-650L
• Device Lot Number: UNKNOWN(LITERATURE)
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: D-201-11804 LOT NUMBER UNKNOWN; FD-410LR LOT NUMBER UNKNOWN; GIF-Q260J SERIAL NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown