MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned.Device evaluation anticipated; but not yet begun.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.
Event or Problem Description
The customer reported to olympus, the thunderbeat probe was skewed/misaligned while being activated in the patient.The issue occurred approximately 30 minutes after use during a laparoscopic sleeve gastrectomy procedure.The instrument was withdrawn with probe still attached to the instrument.Probe dislodged from the instrument once touched outside of patient on scrub trolley.The procedure was completed with a similar device.There was a delay of three minutes and the duration of extended anesthesia or sedation was three minutes.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was returned and an evaluation was completed for it.During inspection, olympus confirmed the reported event, the probe was broken around the outer pipe.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1) during the output activation in seal & cut mode, the distal end of the probe was slightly contacting a thin equipment, causing spark generation.2) a force was applied to the probe during spark generation.3) a force to grasp tissue or a force to activate the output in seal & cut mode was applied to the probe.This generated cracks on the probe.4) due to continuous use of the device, the cracks on the probe progressed.This led to breakage of the probe.The following information is included in the instructions for use (ifu): ¿do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high-frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities.¿ olympus will continue to monitor the performance of this device.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• 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: 16611718
• Report Number: 9614641-2023-00423
• Device Sequence Number: 20111238
• Product Code: GEI
• UDI-Device Identifier: 04953170383519
• UDI-Public: 04953170383519
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: TB-0545FCS
• Device Lot Number: 2JB160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2023
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTHREX IMAGING STACK.; ENDOPATH EXCEL PORTS 15MM X 100MM.; HICURA LAPAROSCOPIC INSTRUMENTS.
• Patient Sex: Unknown