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

Model Number	TB-0920OE
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility initially reported that there was an interface error.It was also reported there was a 3 x 2 cm third degree burn (initially stated to be a second degree burn) on the patient's anus from the contact of the shaft of thunderbeat open extended jaw.The patient was positioned in lithotomy for the therapeutic colorectal surgery for hemorrhoids.The energy of the device was transmitted through the paddles after using the device for two hours as well as through the entire 20 centimeter metal shaft resulting in a damaged shaft from the heat.The procedure was completed with the same device.The burn was found at the end of the surgery; therefore, there was no delay or extended anesthesia.Initial information indicated that plastic surgery may have been required but this was unable to be confirmed.Silvadene was provided and the patient's burn was reported to be cured.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The paddle refers to the probe and grasp.It is unclear which part of the shaft touched the patient.The entire shaft was hot.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.Additionally, to provide information received ((b)(6)).The subject device was manufactured in november 2022, but the specific date is unknown.The version of the software was ver.2.00.The setting of intelligent tissue monitoring (itm) was "on" and the setting of itm is usually "on".The user understood the itm clearly.The user did not change the setting of itm during the procedure.The device was used 2 hours during the procedure.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 the reported event occurred due to the continuous output of the device, the grasping portion became hot.However, the subject device was not returned therefore, a specific root cause could not be determined.The event can be prevented by following the instructions for use which state: "to seal adjacent tissue, overlap the edge of the existing seal.The second seal should be distal to the first seal to increase seal margin.Otherwise, incomplete sealing may cause bleeding and/or the existing seal may be opened." "the grasping section and probe tip become hot due to extended ultrasonic output.Do not let it come in contact with tissues other than the target tissue." olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN EXTENDED JAW
• 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: 17913948
• Report Number: 9614641-2023-01504
• Device Sequence Number: 15305067
• Product Code: GEI
• UDI-Device Identifier: 04953170343315
• UDI-Public: 04953170343315
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

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-0920OE
• Device Lot Number: 2JB252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown