MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP; SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HOLDER/TIP, SINGLE-USE

Model Number	SB-0545FC
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During device evaluation at olympus, it was found the probe was checked and passed.Both switches were checked and found to be functional.A visual inspection found there was slight tissue build up.The teflon pad was inspected and found to have normal wear with no metal exposed and no abnormalities.The distal end of the device was inspected under a microscope and there was no visual indication of damage to the probe unit.The wiper movement was normal.The consistency of movement of the handle and jaw was normal.The handle load was normal and the rotation of the knob torque was normal and smooth.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Event or Problem Description
The customer reported the sonicbeat failed out of the box during a therapeutic sleeve gastrectomy procedure.The device turned red hot about 2 mm above the midpoint (proximal end, tip) of the titanium probe.The probe cooled down in a flexed upward position and the jaws were no longer able to grasp.The procedure was delayed about a minute to open up another sonicbeat device.Anesthesia was not extended and the procedure was completed without incident.No medical intervention was needed.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.¿.

• Brand Name: SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP
• Common Device Name: SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HOLDER/TIP, SINGLE-USE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16617304
• Report Number: 9614641-2023-00433
• Device Sequence Number: 20401276
• Product Code: LFL
• UDI-Device Identifier: 04953170370571
• UDI-Public: 04953170370571
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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
• Operator of Device: Health Professional
• Device Model Number: SB-0545FC
• Device Lot Number: 2ZK 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown