MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number SB-0535FC

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The probe broke 15 millimeters from the probe tip.There were scratches around the broken part.The fracture started from the scratch.In addition, there were traces of contact with the probe on the grip.The tissue pad was severely worn.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus employee reported on behalf of a customer, during a therapeutic uterine myomectomy, the tip of the sonic beat probe broke.The probe dropped and was recovered outside of the patient¿s body.The procedure was completed without delay, using a replacement device (same model).There was no report of additional anesthesia or patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d4 and g2 (healthcare professional was inadvertently selected).  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, a likely mechanism causing the reported event might be the following: 1) the tissue pad was severely worn out because the ultrasound was output with the gripper closed without gripping the tissue (including after the tissue was cut).2)since the tissue pad was worn out, the grasping section and the distal end of the probe came into contact.3)the output was ultrasonic activated in state of description stated above.Therefore, scratches (contact marks) were made on the distal end of the probe and the grasping section, indicating that they came into contact with each other.4)the device was ultrasonic activated or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks.5)a force was applied to the probe causing it to break.The event can be detected/prevented by following the instructions for use which state: "do not activate output while the grasping section is closed without contacting tissue or vessel or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.When cutting or vessel sealing is performed, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation".Olympus will continue to monitor field performance for this device.

• Brand Name: SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• Type of Device: INSTRUMENT
• 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: 17887220
• MDR Text Key: 325122103
• Report Number: 9614641-2023-01477
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 04953170370540
• UDI-Public: 04953170370540
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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
• Device Operator: Health Professional
• Device Model Number: SB-0535FC
• Device Lot Number: 34K27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/25/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female