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

Model Number	T3915
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned but the device evaluation is not yet begun.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.
Event or Problem Description
As reported for this event by the distributor, during a therapeutic laparoscopic inguinal hernia repair part of the device tissue pad fell off.It was confirmed that there were no fallen pieces inside the body.However, the fallen off piece was not found, until a piece presumed to be the fallen off piece was found outside the patient body.The procedure was completed with another device of the same model number.There is no harm or adverse impact to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to d8 and g2.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, it¿s likely that a force was applied to the peeled grasping surface.This might have caused the grasping surface to detach.However, the exact cause of a force applied to the grasping surface could not be determined.Additionally, it's probable the grasping section was closed without grasping anything in between the grasping section and the distal end of the probe when the ultrasonic output was repeatedly activated, as it's unable to be confirmed whether the tissue was completely resected when the ultrasonic output was repeatedly activated.These reasons might have contributed to the worn out and peeling of the grasping surface.Based on the material analysis during the investigation, it was discovered that the foreign material #1 was part of the grasping section.Polyethylene was not used for the product, the foreign material #2 was not related to the grasping surface.A final root cause of these events was unable to be identified.The following is included in the instructions for use: ¿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.¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The returned device has been evaluated.Correction is being made for the device information.This supplemental report is being submitted to provide this information.The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that the tissue pad gripping surface was worn with pieces that had fallen off.The pieces that were fallen off were returned.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

• Brand Name: SONOSURG CURVED SCISSORS,HF,INLINE 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: 16514552
• Report Number: 9614641-2023-00351
• Device Sequence Number: 6611513
• Product Code: LFL
• UDI-Device Identifier: 04953170235689
• UDI-Public: 04953170235689
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2023

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: T3915
• Device Lot Number: 9113792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 03/09/2023; 04/11/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/03/2023; 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2021
• 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-G2.SONOSURG-T2H-C.
• Patient Sex: Unknown