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	04/16/2024
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 ovariectomy, while suctioning, the tip (also stated as golden beak) of the device broke and fell into the abdomen.There was a slight delay to find and remove the tip from the abdomen.The retrieval method was not known.The procedure was completed with the same devices without any further problems.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide correction to the initial with information inadvertently left out (b3) and to provide an update to field (h4).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 and past investigation results, it is likely detachment of the probe which led to recovery of the subject device could have occurred by the following reasons: force was applied to the probe: 1.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.This might have caused the probe to crack.2.The output was activating with cracks in the probe.As a result, a force might have been applied to the probe this caused the probe to break at the cracks.Contact with other devices: 1.The ultrasonic output was activated while the probe was in contact with the hard objects such as clips or forceps, or the probe was scraped by using a sharp object, such as surgical tools to remove foreign substance adhesion.As a result, the probe had scratches.2.A force might have been applied to the probe due to continuous use of the probe with scratches.Therefore, the probe broke at the scratched area.However, the subject device was not returned, and the root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: "·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.·when the probe is contaminated by carbonized the tissue, use a piece of moistened, soft gauze to remove the tissue.Do not attempt to scrape it with a sharp object such as a scalpel.Otherwise, the probe may be scratched or break and detach into the body cavity during ultrasonic output." 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: 19528763
• Report Number: 9614641-2024-01247
• Device Sequence Number: 18044005
• Product Code: LFL
• UDI-Device Identifier: 04953170235634
• UDI-Public: 04953170235634
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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?: No
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown