MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAC-S MICRO VULCAN ANGLED INTEGRATED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	7209629
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that in the literature review "long-term outcomes for arthroscopic thermal treatment for scapholunate ligament injuries"; after arthroscopic electrothermal treatment of low-grade geissler¿s scapholunate interosseous ligament (slil) injuries, using a vulcan rf arthroscopy system with a micro tac-s angled monopolar probe; 1 patient sustained an ipsilateral triangular fibrocartilage complex tear that required treatment.Details about the treatment were not specified, and no further information is available.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Article: burn, m.B., sarkissian, e.J., & yao, j.(2020).Long-term outcomes for arthroscopic thermal treatment for scapholunate ligament injuries.Journal of wrist surgery, 9(01), 022-028.Doi: 10.1055/s-0039-1693973.

• Brand Name: TAC-S MICRO VULCAN ANGLED INTEGRATED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17942169
• Report Number: 3003604053-2023-00062
• Device Sequence Number: 12458212
• Product Code: GEI
• UDI-Device Identifier: 03596010470645
• UDI-Public: 03596010470645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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 Catalogue Number: 7209629
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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