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

Model Number	T3775
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a laparoscopic appendectomy, the probe broke and fell into the abdominal cavity shortly after the procedure began.The physician suspected it may have been defective at the start.The probe was retrieved with forceps and the abdominal cavity was washed.There was an extension of procedure time due to the retrieval, but there was no major impact.The device was replaced from the hospital¿s spare stock; the procedure was then completed without harm to the patient.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's (lm) investigation.The subject device was evaluated by olympus, and the serial numbers of the probe and handle did not match.Also, the probe was confirmed to be broken.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 following mechanism likely caused the reported event: 1.The distal end of the probe was pushed forcefully against the tissue while the output was activated.Or output was activated while.Twisting the scissors and grasping the tissue.This caused the probe to crack.2.A force was applied to the distal probe, causing the probe to break at the cracks.However, the root cause of the event could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿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.¿ ¿do not combine a handle and probe unless they have the same serial numbers.Otherwise, the instrument may be damaged.¿ this supplemental report includes an update to h3 from the initial medwatch.Also, a correction has been made to g2 and h8.Olympus will continue to monitor field performance for this device.

• Brand Name: SONOSURG CURVED SCISSORS,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: 20637357
• Report Number: 9614641-2024-02073
• Device Sequence Number: 7404330
• Product Code: LFL
• UDI-Device Identifier: 04953170234880
• UDI-Public: 04953170234880
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T3775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 GENERATOR: UNK SN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown