MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ULTRASONIC SURGICAL SYSTEM SONOSURG; GENERATOR

Model Number	SONOSURG-G2 SET
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
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 customer reported to olympus the ultrasonic surgical system sonosurg generator was used in combination with the sonosurg scissors when the device was not able to seal a blood vessel when output was activated.The issue occurred during a laparoscopic appendectomy.During the same procedure, hemostasis was achieved using bipolar energy with no blood transfusion being necessary.After hemostasis was achieved, the adipose tissue was sealed successfully.There were no reports of additional patient impact.Related patient identifiers: (b)(6) sonosurg curved scissors, high frequency, with pistol grip.(b)(6) sonosurg transducer.(b)(6) ultrasonic surgical system sonosurg.This report is for (b)(6).
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 obtained through follow up.The manufacture date cannot be identified since the subject device has been manufactured more than 15 years, it has exceeded the dhr retention.Since the device is more than 15 years old, the device history record was unable to be reviewed.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 complaint device could not be inspected.Also, there are no facts to support that sealing (hemostatic) could not be performed due to failure of the device.Therefore, the exact cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: ·if you suspect any abnormality while using this product, immediately stop the procedure.Refer to chapter 7,¿troubleshooting¿ and the instruction manual of the sonosurg hand piece being used.If the information given there does not eliminate the abnormality, terminate the use of the equipment and contact olympus.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was confirmed that an event in which a seal (hemostasis) was not possible was attempted by ultrasonic power manipulation.Additional information obtained through follow-up no knowledge of blood transfusion.The facility reports the procedure time was extended due to the device malfunction.The facility reports it took a long time to stop the bleeding.It is unknown if there are any drugs such as sedatives that were added unexpectedly due to the device malfunction.It is unknown whether or not the patient was discharged from the hospital.However, the users have not heard of any health damage due to the event.

• Brand Name: ULTRASONIC SURGICAL SYSTEM SONOSURG
• Common Device Name: GENERATOR
• 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: 17363709
• Report Number: 9614641-2023-01005
• Device Sequence Number: 6016553
• Product Code: LFL
• UDI-Device Identifier: 04953170170898
• UDI-Public: 04953170170898
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: SONOSURG-G2 SET
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/20/2023
• 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: SONOSURG-T2H-C TRANSDUCER, SERIAL #(B)(6).; T3905 SCISSORS, SERIAL #(B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown