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 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus, and the evaluation of the reported issue is in progress.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported that when removing the instrument from the patient and cleaning it, customer noticed that the tissue pad had completely peeled off.The doctors believed it may have been due to the usg-410-ultrasonic bipolar generator being output for a long time, but not excessively.There was no shedding inside the patient's body.This was succeeding a therapeutic cholecystectomy procedure previously completed using the reported device with no delay.The peeled tissue pad was discarded at the facility, and there was no report of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Update h3.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The tissue pad had fallen off.The piece of tissue pad that fell off was not returned.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 shedding of the pad occurred by the following mechanism(s).The tissue pad was severely 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).Some force was applied to the peeled tissue pad causing it to fall off.The event can be detected/prevented by following the instructions for use which state: "do not activate output in seal & cut mode 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 seal and cut 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 in max & var mode, apply light tension on the tissue so that users can confirm that it is transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, 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: 18378327
• MDR Text Key: 331367521
• Report Number: 9614641-2023-01970
• 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
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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: 37K21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2023
• 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
• Treatment: USG-410-ULTRASONIC BIPOLAR GENERATOR