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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative reported on behalf of the customer that the probe tip of the sonosurg curved scissors, hf, inline grip, 5mm x 9cm broke when it released the tissue upon output or attempt to output.No part of the device fell off into the patient's body.The output was normal and set at 100% and arbitrary setting was at 70%.The issue occurred during a retectomy by laparotomy and was completed with a similar device.The device output was checked prior to use without any issues noted.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The suspect device was returned to olympus.The probe was found broken 16 millimeters from the tip.There was a black discoloration on the probe fracture surface and cracks were spreading from the black discoloration point.There were no scratches around the origin of the probe rupture.It was also observed that the gripping surface was worn out.The event may have occurred due to the load applied to the probe that separated the tissue while the probe cracked from the defect information.It was presumed that the cracks in the probe were caused by excessive load on the probe tip due to the following factors.Output was performed while pressing only the probe tip strongly against the tissue.Output was performed while twisting the scissors while grasping the tissue.It was presumed that the wear of the gripping surface occurred because the gripping part was closed and ultrasonic output was repeated when nothing was gripped between the gripping part and the probe tip or it was not possible to confirm whether the gripping tissue could be separated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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 definitive root cause of the broken probe could not be determined.It is possible that only the distal end of the probe was pushed forcefully against the tissue while the output was activating, or the output was activating while twisting the scissors with grasping the tissue, which may have caused the probe to crack.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.Cracks may have occurred in the detergent channel tube due to external factors, detergent flowed into the crack, or a chemical attack.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿activate the probe only when tissue has been grasped.Do not apply the probe to the tissue with strong force, twist the probe while grasping tissue, or pull the probe up grasping tissue.Otherwise, the probe may be damaged by interference with the internal parts or load increases, which could result in the tip breaking and dropping it inside the body cavity.Do not activate ultrasonic output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such a metal clips or other instruments (e.G., metal clips, uterine manipulators, or other instruments).Do not apply only the probe to the tissue with strong force or do not twist or pull the probe up while grasping the tissue.Otherwise, the probe may become too hot and break before the generator gives a warning lamp/sound.Do not activate ultrasonic output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such a metal clips or other instruments (e.G., metal clips, uterine manipulators, or other instruments).Activate the probe only when tissue has been grasped.Do not apply the probe to the tissue with strong force, twist the probe while grasping tissue, or pull the probe up grasping tissue.Otherwise, the probe may become too hot and break before the generator gives a warning lamp/sound.¿ olympus will continue to monitor field performance for this device.

• 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: 17811915
• Report Number: 9614641-2023-01391
• Device Sequence Number: 6727274
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: T3955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2022
• 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