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

Model Number SB-0535FC

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was not confirmed.It was found that there was severe wear of the tissue pad.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

The customer reported to olympus that the sonicbeat 5 mm, 35 cm, front-actuated grip had the tissue pad come off.The event occurred during a therapeutic total laparoscopic hysterectomy procedure.The procedure was completed using a similar device.There was no patient harm associated with the 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 (inadvertently selected healthcare professional).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 actual product confirmation and the results of the actual product survey, it is likely that the event pointed out occurred by the following mechanism.1.The tissue pad was worn out and part of it peeled off because the ultrasound was output with the gripper closed without gripping the tissue (including after the tissue was cut).2.Ultrasonic output was performed while the tissue pad was peeled off, causing the tissue pad to wear severely and the metal surface to be exposed.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.Do not close the gripping part and output when nothing is grasped between the grasping part and the probe tip, or when it is not possible to confirm whether the living tissue or blood vessel being grasped has been incised.Due to abnormal heat generation caused by friction between the gripping part and the probe tip, the gripping part and the probe tip may be damaged, deformed, or falling off, and part of the tissue pad may peel off, leading to severe wear.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.When treating living tissues or blood vessels, make an incision with light tension so that the incision can be seen.Also, when it is cut off, stop the output immediately.Otherwise, abnormal heat generation due to friction between the tissue pad and the probe tip may lead to damage, deformation, or disconnection of the gripping part (both the stainless-steel part and the fluoropolymer part) and the probe tip, or a part of the tissue pad may peel off".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: 18118221
• MDR Text Key: 327874019
• Report Number: 9614641-2023-01699
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• 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: 33K06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: TD-SB400; USG-400