MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535PC
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	05/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that during a laparoscopically assisted vaginal hysterectomy while using the thunderbeat 5 mm, 35 cm, pistol grip, the tip of the jaw (the rubber) detached during surgery in the patient and was subsequently recovered from the patient.No delay occurred due to the issue, and no error messages were seen.No additional interventions occurred; another thunderbeat was opened and used to complete the procedure successfully.
Additional Manufacturer Narrative
This report was submitted by the importer under the importer's report number 2429304-2023-00189.The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was clarified that it was the tissue pad of the grasping section that had detached.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b5.Correction also made to h6 component code based on additional information received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned to olympus.The reported phenomenon and condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was manufactured in february 2023, but the specific data is unknown.Based on the results of the investigation, the exact cause could not be determined.However, the tissue pad likely fell off due to the following mechanisms: 1.Part of the tissue pad peeled off because the seal & cut output was performed when nothing was gripped in the grip (including after the tissue was cut).2.The tissue pad fell off because a load was applied to the peeled off tissue pad.The event can be prevented by following 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 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 field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP
• 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: 17113743
• Report Number: 9614641-2023-00835
• Device Sequence Number: 17728885
• Product Code: GEI
• UDI-Device Identifier: 04953170308659
• UDI-Public: 04953170308659
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K132703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TB-0535PC
• Device Lot Number: 32K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 08/16/2023; 08/30/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 08/18/2023; 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown