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	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp (omsc).Omsc could not review the service and manufacturing record because the serial number was not provided from the facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature title "efficacy of vonoprazan for the prevention of bleeding after gastric endoscopic submucosal dissection with continuous use of antiplatelet agents".The literature reported the result of 49 cases of the gastric endoscopic submucosal dissection (esd) procedures using an olympus model an insulated tipped (it) knife (kd-611l) and a coagrasper (fd-412lr) between december 2015 and june 2018.In the subject procedures, 1 case of post esd bleeding and 1 case of intraoperative perforation reportedly occurred.Based on the available information, a direct relationship between the subject devices and the observed reported adverse event could not be determined.According to the number of the accidental symptoms known and the number of olympus devices used for the procedure, omsc is submitting 4 medical device reports.This is the 2nd of 4 reports.

• 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
• MDR Report Key: 10065490
• Report Number: 8010047-2020-02765
• Device Sequence Number: 16335088
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FD-412LR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/18/2020
• 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