MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET IQ UNIVERSAL ANGLED HANDPIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5500255000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user from user facility reported that during a procedure, the device had error messages and unable to function that resulted in reschedule of the procedure.This report is being submitted for the rescheduled procedure.
Event or Problem Description
Upon further investigation, it was determined that the procedure was completed.There was no indication that the patient required further medical intervention as a result of this event.Based on the investigation results, this event is not-reportable.
Additional Manufacturer Narrative
Additional information: b5.Device evaluation: follow-up report submitted to document device evaluation results.Correction: upon further investigation, it was determined that the procedure was completed.There was no indication that the patient required further medical intervention as a result of this event.Based on the investigation results, this event is not-reportable.

• Brand Name: SONOPET IQ UNIVERSAL ANGLED HANDPIECE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 21505696
• Report Number: 3015967359-2025-00487
• Device Sequence Number: 11909951
• Product Code: LFL
• UDI-Device Identifier: 07613327298611
• UDI-Public: (01)07613327298611
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 5500255000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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