MAUDE Adverse Event Report: VIOL CO.,LTD. HIGH FREQUENCY SURGICAL DEVICE; SYLFIRM X

Model Number	SYLFIRM X
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On june 15, 2023, viol co.,ltd received an official letter from the fda that an incident report had been received.Based on the contents of the official letter and related medwatch report (mw5118363), an investigation was conducted with (b)(4) an importer, and the following were confirmed.In the report (mw5118363), the reporter said that he/she complained on viol's social media, so (b)(4) and viol's social media were investigated.As a result of the investigation, it was confirmed that two inquiries were made on (b)(4) social media with similar content to the related report (mw5118363).In relationi to this, it was confirmed that (b)(4) who is managing the social media, gave some replies to the inquirer.However, there is little information in the report (mw5118363), so it is difficult to confirm whether the inquirer is the reporter of mw5118363.For this reason, it is difficult to request the hospital to provide patient information ro personal information of the inquirer.Therefore, we request fda to provide the reporter's information for further investigation.If fda provides t he reporter's information, additional investigation will be conducted and follow-up report will be made.

• Brand Name: HIGH FREQUENCY SURGICAL DEVICE
• Common Device Name: SYLFIRM X
• Manufacturer (Section D): VIOL CO.,LTD.; c-808, 809, bundang technopark; c, 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer (Section G): VIOL CO.,LTD.; c-808, 809, bundang technopark; c, 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• Manufacturer Contact: jeawon song ; c-808, 809, bundang technopark; c, 744, pangyo-ro, bundang-gu; seongnam-si, gyeonggi-do 13510 ; KS 13510
• MDR Report Key: 17313430
• Report Number: 3009206941-2023-00002
• Device Sequence Number: 14452081
• Product Code: GEI
• UDI-Device Identifier: 08809502330101
• UDI-Public: 08809502330101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K213612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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
• Device Model Number: SYLFIRM X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown