MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 19CM; ULTRASONIC SURGICAL DEVICE

Model Number	T3935
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The evaluation uncovered the probe was broken at a position 16.5 mm from the tip.There was no broken probe tip.When the fracture surface was checked, there was a black discoloration on the probe fracture surface.The cracks spread from the black discolored part.There were no scratches around the starting point of the probe rupture.The grip surface was worn.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The customer reported to olympus during a gastrointestinal surgery, the probe broke and the debris from the probe was recovered from the sonosurg curved scissors,hf,pistol grip,5mm x 19cm.The procedures were completed successfully using a similar device.There were no reports of patient harm associated with this event.
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, it is possible that the reported event of the probe cracking occurred due to the following: "the output was performed while pressing only the tip of the probe strongly against the tissue." or "the output was performed while twisting the scissors while holding the tissue." the probe cracked.A load was applied to the tip of the probe, and the probe broke from the crack.The other reported issue of wear and tear was possibly due to the following: the wear of the gripping surface was caused by the fact that the gripping portion was closed and ultrasonic output was repeated in a state where nothing was gripped between the gripping portion and the tip of the probe or when it was not possible to confirm whether the gripping tissue could be separated.I guess it happened.A definitive root cause cannot be identified.This issue is covered in the instructions for use: do not close the grip and output when nothing is gripped between the grip and the tip of the probe, or when it cannot be confirmed whether the tissue being gripped has been separated.Abnormal heat generation due to friction between the grip and the tip of the probe may cause damage, deformation, dropout of the grip, and severe wear of the grip surface.When outputting ultrasonic waves, do not output while twisting the insertion part or turning the rotary knob while gripping hard or thick tissue.The load on the probe may increase, leading to breakage or dropout, or the probe may interfere with internal components and damage the probe, leading to breakage or dropout.This product is intended for soft tissues.Do not output ultrasound while holding a hard tissue such as bone or calcified tissue with the tip of the probe, or a metal clip or other surgical device (such as a uterine manipulator).The probe may become hot and break before the ultrasonic output warning indicator lights up or the warning sound is heard.Olympus will continue to monitor the field performance of this device.

• Brand Name: SONOSURG CURVED SCISSORS,HF,PISTOL GRIP,5MM X 19CM
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14466616
• Report Number: 8010047-2022-08696
• Device Sequence Number: 4685706
• Product Code: LFL
• UDI-Device Identifier: 04953170235153
• UDI-Public: 04953170235153
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: T3935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2016
• 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