MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number	SB-0545FC
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the tissue pad was heavily worn.The probe had a crack at 12 mm from the tip.The probe had contact marks with the gripper.There were marks on the gripping area where the probe had come into contact with the gripper.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
As reported for this event by the customer, 30 minutes into a therapeutic laparoscopic cholecystectomy procedure a metallic noise was heard and the device tissue pad was found to be very worn.Error message receive is not known.The procedure was completed with a new similar device.There is no harm or adverse impact to the patient.The device was inspected prior to use with no anomaly noted.The setting at the time of the event were maximum 3/variable 1.Intelligent tissue monitoring (itm) functionality was on during the procedure.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1.Ultrasonic output was performed while the tissue was gripped by the tip of the grip.2.The probe and tissue pad came into contact with each other on the rear end side of the grip, and the tissue pad was severely worn.3.Since the output was made with the probe and non-insulated part in contact, a metallic sound was generated.In addition, contact marks (scratches) were generated.4.Ultrasonic vibration and a load to grip the tissue are applied to the probe, causing cracks starting from scratches and causing an error.This following information is included in the instructions for use (ifu): ¿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 the performance of this device.

• Brand Name: SONICBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15125333
• Report Number: 9614641-2022-00060
• Device Sequence Number: 5736802
• Product Code: LFL
• UDI-Device Identifier: 04953170370571
• UDI-Public: 04953170370571
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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
• Operator of Device: Health Professional
• Device Model Number: SB-0545FC
• Device Lot Number: 1YK 08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: USG-400TD-SB400
• Patient Sex: Unknown