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

Model Number	TB-0920OE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pseudoaneurysm (2605); Hematemesis (4478); Melena (4480)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described that the device used was a "thunderbeat open jaw", olympus selected "tb-0920oe" as a representative product.The suspect device referenced in this report has not been returned to olympus.Additional information has been requested but no information could be provided.The literature is for additional information.This was translated to english electronically from its original japanese copy.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "a case of ruptured gastroduodenal artery pseudoaneurysm 2 months after gastrectomy".Summary: the patient is an 83-year-old female.An open distal gastrectomy (d2 dissection, billroth i reconstruction) was performed for gastric cancer, and the patient was discharged from the hospital on the 15th postoperative day without any complications.The patient was diagnosed with pt2 (mp) n3bmo, pstage iiib, and was treated with postoperative adjuvant chemotherapy using ts-1 alone.On the 65th postoperative day, the patient suddenly developed hematemesis and melena, and contrast-enhanced ct revealed bleeding from a pseudoaneurysm in the gastroduodenal artery, so arterial embolization was performed.The patient was discharged from the hospital 30 days after embolization.Bleeding due to rupture of a pseudoaneurysm after gastrectomy is rare, and most cases occur secondary to suture failure or pancreatic fluid leakage within one month after surgery.On the other hand, there are also reports of arterial damage caused by the heat generated by devices such as ultrasonic coagulation and cutting devices, resulting in the formation of pseudoaneurysms.Perioperative management and appropriate device operation were considered important, keeping pseudoaneurysm rupture in mind as a complication of gastrectomy.There is no report of any olympus device malfunction in any procedure described in this study.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.This supplemental report includes additional information received from the author.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The author provided the following additional information: it is possible that the olympus device was related to the adverse event; however, it could not be determined.It cannot be verified, as the procedure was not reordered.From the nature of energy device, thermal effect and capitation can cause the adverse events described in the article.Thus, it cannot be ruled out that the thunderbeat was related.However, it was confirmed that an olympus device malfunction did not occur.
Additional Manufacturer Narrative
This report is being supplemented to provide the official english translation of the literature.Please see attached.

• 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: 18355868
• Report Number: 9614641-2023-01952
• Device Sequence Number: 12364105
• Product Code: GEI
• UDI-Device Identifier: 04953170343315
• UDI-Public: 04953170343315
• 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,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TB-0920OE
• Was Device Available for Evaluation?: No
• 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: 11/24/2023
• Supplement Date Received by Manufacturer: 01/26/2024; 01/30/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/26/2024; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female