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

Model Number	SB-0520FC
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.And the customer's allegation was confirmed.The device evaluation found the tissue pads were severely worn.Additionally, there was a trace of contact with the tip of the probe on the grip.The probe also had contact marks, which indicated that the probe and the grasping section came into contact.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation.It is likely, that the following led to the malfunction: 1.When nothing was grasped between the gripper and the probe (including after the tissue was cut).The tissue pad was severely worn and smoke was generated, because the gripper was closed and ultrasonic waves were output.2.The tip of the probe came into contact with the grip part, due to wear of the tissue pad.By continuing to output in the state of 3.2, a load was applied to the probe and a probe damage error (error code: u504) occurred.In addition, contact traces were generated.However, a definitive root cause could not be determined.The device's instruction manual provides the following warnings, which may help to prevent the issue: 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 field performance of this device.
Event or Problem Description
The customer reported to olympus, that during a therapeutic laparoscopic conversion for cholecystectomy surgical procedure.Smoke occurred from the sonicbeat 5 mm, 20 cm, front-actuated grip, with an error message at the olympus generator.The error message e504 was presented.The plastic of the clamp melted.The intelligent tissue monitoring functionality was turned on.Inspection and testing of the returned device found the tissue pads were severely worn.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• Brand Name: SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16870487
• Report Number: 9614641-2023-00615
• Device Sequence Number: 5796502
• Product Code: LFL
• UDI-Device Identifier: 04953170370601
• UDI-Public: 04953170370601
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• 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: 01/17/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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-400 ULTRASONIC GENERATOR
• Patient Sex: Unknown