MAUDE Adverse Event Report: COVIDIEN SONICISION 7; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SCD7A39
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device defect.Door to lock battery would not lock in place.Event occurred while setting up care for the procedure in the or.

• Brand Name: SONICISION 7
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 24160628
• Report Number: 24160628
• Device Sequence Number: 9019608
• Product Code: LFL
• UDI-Device Identifier: 10884521794795
• UDI-Public: (01)10884521794795(17)301014(10)52880278X(20)02
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/19/2025
• Report Date (Section F): 12/19/2025

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: SCD7A39
• Device Lot Number: 52880278X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• 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: 12/19/2025