MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned but the device evaluation is not yet completed.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.
Event or Problem Description
As reported for this event by the customer, shortly after starting a therapeutic laparoscopy-assisted distal gastrectomy (ladg) procedure, the device probe broke off into the patient.The broken piece was retrieved from the patient.The procedure was completed with a new similar device.There is no harm or adverse impact to the patient.The output of the device was done only a few times with the tissue pad hardly worn when the event occurred.The settings at the time of the event are not known.The user is experienced in the use of the device.
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 at 15mm from the distal end of the probe.Additionally, the tissue pad was worn out; however, this defect is not considered severe enough to cause a potential adverse event.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.The output was activated in seal & cut mode while the distal end of the grasping section was grasping a hard and thick tissue.Therefore, the probe came into contact with the tissue pad at the rear end of the grasping section.As a result, the tissue pad was worn out.2.Since the tissue pad was worn out, the non-insulated area of the grasping section came into contact with the probe.3.The output was activated while the non-insulated area of the grasping section was contacting the probe.This caused scratches on the probe.4.A force to activate the output in seal & cut mode, or a force to grasp a tissue might have been applied to the probe.Therefore, the cracks started from the scratched area.5.A force was applied to the probe causing it to break.The following information is included in the instructions for use (ifu): ¿do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.¿ ¿when cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm it is transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation.¿ 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14889432
• Report Number: 8010047-2022-11221
• Device Sequence Number: 5162928
• Product Code: GEI
• UDI-Device Identifier: 04953170409684
• UDI-Public: 04953170409684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2022

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: 1XK 15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400TD-TB400
• Patient Sex: Unknown