MAUDE Adverse Event Report: GYRUS ACMI, INC SOLTIVE; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-FBX200BS
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Laser wire broke during surgery.Dr's left thumb was burned.

• Brand Name: SOLTIVE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 23988693
• Report Number: 23988693
• Device Sequence Number: 4578375
• Product Code: GEX
• UDI-Device Identifier: 00821925043985
• UDI-Public: (01)00821925043985
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2025
• Report Date (Section F): 11/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TFL-FBX200BS
• Device Catalogue Number: TFL-FBX200BS
• Device Lot Number: PW310826
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/17/2025