MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONOSURG CURVED SCISSORS,HF,INLINE GRIP,5MM X 9CM; ULTRASONIC SURGICAL DEVICE

Model Number	T3955
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported when the product was disassembled during reprocessing after a coronary artery bypass grafting (cabg), it was noticed that the black rubber ring attached to the active blade was missing.The procedure had already been completed and there was no impact on the procedure or patients health.The patient's current status is unknown.The fallen rubber ring was not collected.Per the facility, if the rubber ring can fall off when the product is assembled, it is assumed that there is a possibility that it may have fallen off inside the patient's body and the most likely location would be the posterior part of the lower leg.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, since the subject device was not returned to olympus for evaluation, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "be sure to prepare and inspect the following before use.In addition, related equipment used in combination with this product should also be inspected in accordance with their ¿package inserts or electronic package inserts¿ and ¿instruction manuals¿.¿ ¿do not use it if you suspect any abnormality and take action according to chapter 8.¿ ¿if you still suspect an abnormality, please contact the endoscope customer service center or our designated services.Please contact the center, our branch office, or our sales office.The use of equipment with suspected abnormalities may not only prevent it from functioning properly but may also injury the patient's tissues.¿ ¿be sure to check each case and if you suspect any abnormalities, discontinue use, and use a spare product.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to b5 and h4.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that device defect was discovered during reprocessing of the device after harvesting the blood vessels (grafts) to be used during a coronary artery bypass grafting (cabg) procedure.During disassembly of the device, the dislodged lining was observed to be at the very tip of the probe.There was no confirmation that the broken device piece fell off and into the patient¿s body.There were no abnormal noises noted during the surgical case.The patient did not require any additional treatment and has no health problems related to this event at this time.Furthermore, the facility reports that their device reprocessing steps are as follows: 1.Disassembly.2.Handwashing.3.Automatic cleaning (using mild detergent).4.Sterilization (autoclave).

• Brand Name: SONOSURG CURVED SCISSORS,HF,INLINE GRIP,5MM X 9CM
• 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: 19554067
• Report Number: 9614641-2024-01266
• Device Sequence Number: 6715927
• Product Code: LFL
• UDI-Device Identifier: 04953170235733
• UDI-Public: 04953170235733
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: T3955
• 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: 05/26/2024
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown