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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the thunderbeat open fine jaw type x handpiece could not be removed from the transducer (td-tb400) and the handpiece became stuck.The thunderbeat handpiece was wrecked during the process of trying to remove the transducer.The issue was found during an unspecified therapeutic procedure, the intended procedure was completed using a similar device.There were no reports of patient harm.Related patient identifier: (b)(6).
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found that while checking the distal end of the device under a microscope, the probe was detached (the missing portion was not returned).The device was attached to the usg-400 ultrasonic generator / esg-400 electrosurgical high frequency generator while a probe check was performed and the device failed the probe check with an error code of u509 (probe damage error code), and the ptfe pad (teflon pad) was found to be partially lifted but no metal was exposed.The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as additional information/clarification to b5.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 probe broke due to contact with a surgical instrument or the non-insulated area of grasping section.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 probe came into contact with hard tissue, metal objects or surgical instruments.This resulted in scratches.2.A force to activate the output in seal & cut mode, or a force to grasp the body tissue was applied to the probe.Therefore, cracks were branching from the scratches on the probe.3.The probe broke when that when removing the tb-0009ofx from the td-tb400, a load might have been applied.Or 1.Grasping section was closed without grasping anything while the output was activated in seal & cut mode (this includes after tissue resection).This caused the tissue pad to wear out.2.The tissue pad was worn out.This has resulted in the non-insulated area and the distal end of the probe coming into contact with each other.3.The output was activated in seal & cut mode in state of above description.This has resulted in scratches (contact marks) on the two distal ends of the probe and on the grasping section.4.A force was applied to the probe to activate the output in the seal & cut mode, or a force was applied to grasp the tissue.This resulted in cracks branching at the scratched area.5.The probe broke when that when removing the tb-0009ofx from the td-tb400, a load might have been applied.The following are the instructions for use which state: "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 that they are 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.Make sure that the thunderbeat instrument and the transducer are connected firmly.If they are secured erroneously or only with the hand, energy output may not be available and damage to the transducer or excessive heating of the exterior may also result.Even if output is available, the functionality and durability may be compromised.Use the provided torque wrench and stabilizer for the connection and disconnection and be sure to follow the instructions given in this manual.If another tool, a hand, or excessive force is used for securing, incomplete connection or damage may result to the thunderbeat instrument, or the transducer resulting in the impossibility of disconnection.If proper connection is impossible, there may be a deformation such as crushing or bending in some parts.Inspect the instrument well and immediately stop using it if any irregularity is observed.Stop application of force to the torque wrench when an audible click is heard.Otherwise, the system may not work properly and serious injury to the surgeon, surgical staff, and/or the patient may result".Olympus will continue to monitor field performance for this device.
Event or Problem Description
During the device evaluation, it was confirmed that the broke was broken.This report is being submitted for the broken probe.Additionally, the customer provided additional information which confirmed that the damaged device did not fall into the patient's body or on the ground.The customer had trouble separating the device from the handpiece.The damaged transducer event occurred after the procedure during clean up.There was no impact to the patient or the procedure.

• 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: 17510519
• Report Number: 9614641-2023-01148
• Device Sequence Number: 5607708
• Product Code: GEI
• UDI-Device Identifier: 04953170394584
• UDI-Public: 04953170394584
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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-0009OFX
• Device Lot Number: 32K 02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• 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: 07/14/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown