MAUDE Adverse Event Report: STRYKER INSTRUMENTS SONOPET IQ; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	5500050000
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Burn noted by surgeon to patient's left nostril.Sonopet handpiece removed from sterile field.Plastic sleeve was noted to be melted.

• Brand Name: SONOPET IQ
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 22991096
• Report Number: 22991096
• Device Sequence Number: 12990303
• Product Code: LFL
• UDI-Device Identifier: 07613327364675
• UDI-Public: (01)07613327364675
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/29/2025
• Report Date (Section F): 07/29/2025

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
• Operator of Device: Health Professional
• Device Model Number: 5500050000
• Device Catalogue Number: 5500-050-000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 09/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/29/2025