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	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the black part of the insertion part of the subject device came off and the stainless-steel pipe inside was exposed.The reported issue was observed during an unspecified therapeutic procedure.The intended procedure was completed using another device without a delay.Reportedly, the peeled part was the insulating part on the outside of the insertion part and there was no dropout into the patient¿s body.There was no report of patient or user injury due to the event.The subject device was returned to olympus for evaluation.Upon inspection and testing of the device, it was observed that the gripping surface was peeling off.This report is being submitted for the malfunction found during device evaluation (peeling of gripping surface).
Additional Manufacturer Narrative
During inspection and testing, the customer's reported issue was confirmed.It was observed that the insulation coating at the insertion site was torn, and scratches were observed around the tear.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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, 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 reported event may have been caused by a tear in the coated portion of the insulated area of the insertion portion.Based on past investigation result, it can be inferred that the insulation tube already had scratches during autoclaving.This might have caused the damaged area to spread open.A sharp object and the insulation tube came into contact during insertion of the trocar, or reprocessing of the device.As a result, the insulation tube had scratches.The content of the instruction manual was confirmed.The instruction manual contains the necessary information to handle the device as follows: - 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.- when inserting the instrument into or removing it from the trocar tube, do not apply excessive force.If the instrument is difficult to insert, extract it from the trocar tube and make sure that it is not damaged.Attempting to insert or remove the instrument with excessive force may cause damage and/or make it impossible to remove the instrument from the trocar tube.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: 17821306
• Report Number: 9614641-2023-01407
• Device Sequence Number: 6161665
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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: 09/21/2023
• 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: 09/25/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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