MAUDE Adverse Event Report: INNOVAQUARTZ LLC PROFLEX¿; POWERED LASER SURGICAL INSTRUMENT

Model Number	SINGLE USE 200 LASER LITHOTRIPSY FIBER
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a urology surgical procedure using a laser fiber and machine supplied by rocky top litho, a laser wire burst in the provider's hands and had to be removed from the field.

• Brand Name: PROFLEX¿
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): INNOVAQUARTZ LLC; 23030 north 15th avenue; phoenix AZ 85027
• MDR Report Key: 24828606
• Report Number: 24828606
• Device Sequence Number: 21440196
• Product Code: GEX
• UDI-Device Identifier: 00816959020521
• UDI-Public: (01)00816959020521
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/06/2026
• Report Date (Section F): 04/06/2026

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: SINGLE USE 200 LASER LITHOTRIPSY FIBER
• Device Catalogue Number: S-LLF200LT, S-LLF200TG, S-LLF2
• Device Lot Number: 25125002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/06/2026