MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem No Apparent Adverse Event (3189)

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

Event Date 08/23/2023

Event Type  malfunction  

Event Description

A customer reported to olympus an out of the box failure with a thunderbeat.During an unspecified procedure, there was an unknown probe error and then the device failed.The patient was under anesthesia longer due to retrieving another probe from stock.The procedure was completed with the replacement device.There was no report of medical intervention or patient harm associated with this event.

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is to provide a correction to the pervious initial report mdr as a non-reportable malfunction was reported.The initial medwatch reported that during the procedure a thunderbeat probe error occurred, and the patients anesthesia was extended for the duration it took to retrieve another probe from the stock.The procedure was completed with another similar device.The condition of the patient was not impacted by the failure and no medical intervention was required as a result of the reported problem.The procedural delay is not considered life-threatening, nor did it lead to a permanent impairment in the patient.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Update to d9, h3, and h6 for device receipt.Confirmation was received that patient health was not impacted by the anesthesia extending longer than normal due to locating a replacement probe for the procedure.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device was attached to the ultrasonic generator (usg-400/esg-400) device and a probe check was performed; the device failed the probe check error u510.Both switches were checked and found both switches functional.A visual inspection on the ¿as received¿ condition was performed on the device; there is visual residue on the distal end.The ptfe pad (teflon pad) was inspected and found to have some foreign material located on the pad.The distal end of the device was inspected under a microscope and found no visual indication of damage to the probe unit.Mq was able to verify the condition of the wiper mover is in working condition, still intact with the hand piece.The handle load is normal.The rotation of the knob torque is normal and smooth.User¿s request was able to be confirmed.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, the exact cause of the event couldn¿t be exclusively identified.However, based on the past investigation results, the ultrasonic frequency error was possibly occurred due to contact with a surgical instrument or the non-insulated area of grasping section.The potential mechanism is shown below.During output in seal & cut mode, the probe came in contact with hard tissue, metal or a surgical instrument.Consequently, a scratch was made on the probe and the ultrasonic frequency error occurred.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.When cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm 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.The thunderbeat instrument should be used for soft tissue.Do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator, forceps, and others).Otherwise, it may cause the probe tip to be scratched or come into direct contact with the metal area of the grasping section as the heat generated by the friction between the hard object and the probe tip could cause wear/deforming/splitting/protruding/partial separating of the tissue pad.In turn, the probe may break before displaying an error window or generating an alarm tone.Do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high-frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities".Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• 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: 17866062
• MDR Text Key: 324875614
• Report Number: 9614641-2023-01457
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/22/2024

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: TB-0535FCS
• Device Lot Number: KR332623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 12/07/2023; 01/19/2024
• Supplement Dates FDA Received: 12/11/2023; 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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