MAUDE Adverse Event Report: MicroAire Surgical Instruments PAL System; Instrument Cable for PAL Handpiece

Model Number	5006-PAL
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction

• Brand Name: PAL System
• Common Device Name: Instrument Cable for PAL Handpiece
• Manufacturer (Section D): MicroAire Surgical Instruments; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer (Section G): MicroAire Surgical Instruments; 3590 grand forks blvd; charlottesville VA 22911
• Manufacturer Contact: christina weiss ; 3590 grand forks blvd; charlottesville, VA 22911 ; +1(434)975-8360
• MDR Report Key: 50090965
• Report Number: 2020601-2026-00006
• Device Sequence Number: 18721440
• Product Code: QPB
• UDI-Device Identifier: 00847399003812
• UDI-Public: (01)00847399003812(11)231226
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2026

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: 5006-PAL
• Device Catalogue Number: 5006-PAL
• 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: 06/30/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown