MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SB-0545FC
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus grip device wouldn't fire during surgery.

• Brand Name: SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 3500 corporate pkwy.; center valley PA 18034
• MDR Report Key: 7973558
• Report Number: 7973558
• Device Sequence Number: 18882361
• Product Code: LFL
• UDI-Device Identifier: 04953170370571
• UDI-Public: (01)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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2018
• Report Date (Section F): 10/05/2018

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: SB-0545FC
• Device Lot Number: 86K
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 96
• Date Report Sent to FDA: 10/05/2018