MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM; ULTRASONIC SURGICAL DEVICE

Model Number	T3905
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fistula (1862); Pneumonia (2011)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the literature described "sonosurg",olympus selected "t3905" as a representative product.Once the investigation has been completed, a supplemental report will be submitted with the device evalaution results.
Event or Problem Description
Olympus medical systems corp.(omsc) received a literature titled "mo36-1 a case of single hole laparoscopic window opening for giant hepatic cyst with intraoperative prevention of bile leak by combined use of icg fluorescence."     ¿literature summary¿ the patient is an 84-year-old man.He was referred to our department after an abdominal ct scan revealed an 18.7 cm diameter liver cyst in the s2 of the liver.On physical examination at the time of admission, a huge abdominal bulge with mobility was seen in the left upper abdomen.The diagnosis of a symptomatic giant simple hepatic cyst was made, and a single hole laparoscopic window opening was performed.The laparoscope was an olympus visera elite ii with ir mode after intravenous icg.First, the liver cyst was punctured with a sand balloon, and after aspirating the fluid (1900 ml), the cyst wall with poor fluorescence was dissected with sonosurg while using ir mode.After cauterizing the cyst wall, the cyst wall was observed again with ir mode, and a small amount of icg was found leaking from the dissected edge of the cyst wall.We considered it to be a bile scar and clipped the same area, after which the surgery was completed.The operation took 1 hour and 41 minutes, and there was only a small amount of bleeding.The patient developed aspiration pneumonia postoperatively, but was discharged on the 12th postoperative day without serious intra-abdominal complications such as bile scar.Bile scar is one of the serious complications of hepatic cyst opacification.In this report, we describe a case of a single hole laparoscopic window opening for a giant hepatic cyst, in which a small bile duct collapse was detected intraoperatively with the use of icg fluorescence, preventing bile duct scarring before it occurred.    ¿type of adverse events/number of patients¿ event 1:a small amount of icg leakage was observed from the excision margin of the cyst wall (biliary fistula) - 1 patient event 2:aspiration pneumonia - 1 patient.
Event or Problem Description
Additional information obtained from the author confirms the ve2 (visera elite 2) and the ssg (scientific solutions group) are not relevant to this case.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the author b5.
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 events 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.Olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 34CM
• 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: 18646226
• Report Number: 9614641-2024-00263
• Device Sequence Number: 8276566
• Product Code: LFL
• UDI-Device Identifier: 04953170235665
• UDI-Public: 04953170235665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050885
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2024

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: T3905
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/12/2024; 03/27/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 03/12/2024; 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS VISERA ELITE II, SN- UNK
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male