MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN FINE JAW TYPE X; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0009OFX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, that the ultrasonic surgical device exhibited peeling of the tissue pad.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the error and probe breakage occurred due to contact with a surgical instrument or the non-insulated area of the grasping section.The possible mechanisms are as follows: during seal & cut mode output activation, the probe came into contact with hard tissue, metal, or a surgical instrument, resulting in a scratch on the probe and causing the seal & cut short circuit error.Seal & cut mode was activated when the grasping section was closed without grasping tissue (this includes after tissue resection).This resulted in wear on the tissue pad.Due to the wear of the tissue pad, the non-insulated area of the grasping section came into contact with the probe.In addition, a seal & cut short circuit error (error code: u508) occurred.Seal & cut mode was activated under the described condition, and scratches (contact marks) were generated when the probe contacted the distal end of the grasping section.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN FINE JAW TYPE X
• 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: 20158460
• Report Number: 9614641-2024-01788
• Device Sequence Number: 4247764
• Product Code: GEI
• UDI-Device Identifier: 04953170435829
• UDI-Public: 04953170435829
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: Other
• Device Model Number: TB-0009OFX
• Device Lot Number: 3ZK27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2023
• 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