MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number	FD-412LR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
On jun 15, 2020, olympus medical systems corp.(omsc) received literature titled "a case of gastric pseudoaneurysm following endoscopic submucosal dissection of early gastric cancer".In the literature, it was reported that bleeding and pseudoaneurysm were observed in a patient with the endoscopic submucosal dissection.During esd, no muscular layer of damages or perforations were evident, and there was no bleeding that was difficult to stop.The esd procedure was performed using the electrosurgical knife (dualknife, it-knife).In the case of bleeding, hemostasis was performed using high-frequency hemostatic forceps (coagrasper g) and argon plasma coagulation (apc).The model number was not identified.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.However, in the literature, it was reported that high-frequency coagulation at the time of hemostasis during or after esd was considered to have the following influence.A penetrating vessel from the left gastric artery in the muscular layer at the mucosal defect may have collapsed, resulting in the formation of the pseudoaneurysm, which ruptured due to the influence of gastric acid.Therefore, omsc will submit 2 medical device reports (mdr) for each device.This report is 2 of 2 reports for the electrosurgical hemostatic forceps.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and a correction.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 HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• 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: 10263897
• Report Number: 8010047-2020-04274
• Device Sequence Number: 2329578
• Product Code: KNS
• UDI-Device Identifier: 04953170359804
• UDI-Public: 04953170359804
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: FD-412LR
• 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: 06/15/2020
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 06/29/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female