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	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The ultrasonic surgical device was sent to an olympus service center for evaluation with a report that there was black rubber material that came out from inside the handle while cleaning.The customer also noted that they were not able to collect the rubber parts, so they would like to confirm that there are no missing parts inside.There were no reports of patient harm associated with this event.During inspection, it was found that some of the internal silicone rubber had peeled off, and the gripping surface had peeled off.The medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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.Based on the results of the investigation, event 1 "peeling of the silicone rubber" it is possible that the silicone rubber peeled off due to repeated loads during cleaning the inside of the handle and inserting and removing the probe.Based on the condition of the device, it can be inferred that force was repeatedly applied when cleaning the inside of the handle or inserting/removing the probe.This may have caused the silicone rubber to peel off.Additionally in event 2 "detachment of the grasping surface" it is possible that the wear and peeling of the grasping surface occurred because the grasping part was closed, and ultrasonic output was repeatedly performed without grasping between the grasping part and the probe tip or in a state where it was not possible to confirm whether the grasping tissue could be separated.The grasping section might have been closed without grasping anything in between the grasping section and the distal end of the probe when the ultrasonic output was repeatedly activated, or it was not possible to confirm whether the tissue was completely resected when the ultrasonic output was repeatedly activated.These reasons might have been contributed to the worn out and peeling of the grasping surface.The event can be detected/prevented by following the instructions for use which state: "do not activate output when closing the instrument and nothing is grasped between the grasping section and the probe, or when it is not possible to confirm that the tissue being grasped has been completely resected.Otherwise, abnormal heat generated by friction between the grasping section and the probe may damage the grasping section or cause it to detach or premature wear in the grasping surface.Do not close the gripping part and output it without grasping anything between the gripping part and the probe tip, or when it is not possible to confirm whether the grasping tissue has been separated.Abnormal heat generation due to friction between the gripping part and the probe tip may lead to breakage, deformation, falling off, and severe wear of the grasping surface.This instrument is delicate.Take care when inspecting, preparing, and operating it.This product is a precision instrument, so please handle it with care.Rough handling may result in damage or failure.Be sure to check before each case, and always pay attention to the condition of this product during surgery".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: 18039005
• Report Number: 9614641-2023-01640
• Device Sequence Number: 15496685
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T3905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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
• Patient Sex: Unknown