MAUDE Adverse Event Report: GYRUS ACMI INC. SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SB-0545FC
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
No report to the reporter of malfunction.

• Brand Name: SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): GYRUS ACMI INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 16973816
• Report Number: 16973816
• Device Sequence Number: 15134347
• Product Code: LFL
• UDI-Device Identifier: 04953170370571
• UDI-Public: 04953170370571
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/08/2023
• Report Date (Section F): 05/08/2023

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: SB-0545FC
• Device Lot Number: 2JB238 (2XK)
• 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: 05/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 107 KG
• Patient Race: White
• Date Report Sent to FDA: 05/08/2023