MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number	SB-0520FC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus employee reported on behalf of a customer, during a therapeutic operation the physician grabbed the tissue with a sonicbeat and the tissue pad was burned.This was the first output and at an unknown setting value.No shedding occurred with the tissue pad.The procedure was completed with a replacement device.There was no report of patient harm with this event.During incoming inspection, the tissue pad partially peeled off.The detachment of the tissue pad was caused by the ultrasound being output with the grasping part closed without gripping the tissue, causing the tissue pad to be partially peeled.This medwatch is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.Burning of tissue pad may have occurred due to protein contained in blood being carbonized.In addition to evaluation in b5, the tissue pad was worn and torn.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.
Additional Manufacturer Narrative
Additional information has been received from the customer.This supplemental report is being submitted to provide this information in b5 as well as additional information based on the legal manufacturer's final investigation.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 scenario likely caused the event: it is speculated that the tissue pad was worn, partly peeled off, and torn because the ultrasonic wave was output in a state in which the grasping part was closed without grasping the tissue (including after the tissue was cut).The 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.
Event or Problem Description
The customer provided additional information: patient information is unknown.The procedure was thoracic surgery.No health hazard.No additional treatment.

• Brand Name: SONICBEAT 5 MM, 20 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 (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: 16895225
• Report Number: 9614641-2023-00637
• Device Sequence Number: 20322437
• Product Code: LFL
• UDI-Device Identifier: 04953170370601
• UDI-Public: 04953170370601
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: SB-0520FC
• Device Lot Number: 28K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• 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: 04/12/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: USU-400 BNO.9710901
• Patient Sex: Unknown