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 Fracture (1260)

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

Event Date 07/23/2023

Event Type  malfunction  

Event Description

A customer reported to olympus, during a total laparoscopic hysterectomy (tlh) and while cutting around the cervix, the thunderbeat gave an error and requested a probe test.While the doctor performed the test outside of the patient, he tried to put the subject device back in, and the tip broke off inside the trocar.The tip got stuck to the wall of the trocar.There was no report of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation but 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 report is being supplemented to provide additional information received from the customer and a correction.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Additional information was received from the customer which confirmed the event (error and broken tip) occurred during a therapeutic procedure.The procedure was completed using a similar device with a 1 minute delay.The patient was under general anesthesia and there was no patient harm or consequence reported as a result of the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to inspection results inadvertently left out of previous report.The customer's complaint was confirmed.The probe was broken at 10 mm from the distal end.Scratches were observed around the broken area of the probe.The crack was widening from the scratched area.There were no scratches or contact marks at the non-insulated area of the grasping section.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, a likely cause of the broken probe and error might be the following: 1) during the output activation in seal & cut mode, the probe was contacting hard tissue, metal objects or surgical instruments.2) due to ultrasonic vibration, the coating of the probe peeled off.Also, scratches were generated.3) a force to activate the output in seal & cut mode, or a force to grasp the tissue was applied to the probe.Therefore, cracks were generated at the scratched area and the error occurred.4) a force was applied to the probe causing it to break.A definitive root cause cannot be identified.The event can be detected/prevented by following the instructions for use which state: - "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: 17585007
• MDR Text Key: 321552543
• Report Number: 9614641-2023-01201
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383557
• UDI-Public: 04953170383557
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2023

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
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: KR316676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/01/2023; 10/18/2023
• Supplement Dates FDA Received: 09/12/2023; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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