MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN FINE JAW TYPE X; ULTRASONIC SURGICAL DEVICE

Model Number TB-0009OFX

Device Problem Fracture (1260)

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

Event Date 08/04/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The probe was broken 21 millimeters from the tip.There were scratches around the broken part.Examining the fractured surface of the probe, cracks were progressing starting from the scratches.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

An olympus employee reported on behalf of a customer, during a procedure, the thunderbeat probe was broken and separated.The probe fell outside of the patient.The therapeutic head and neck tumor resection was completed without delay using a replacement device.There was no report of additional anesthesia or patient harm associated with this event.

Manufacturer Narrative

This report is being supplemented to provide 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.Based on the results of the investigation, results alone could not identify the cause exactly.Based on the past investigation results, a likely cause of the phenomenon of the reported event 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) scratches were generated on the probe.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.4) a force was applied to the probe causing it to break.The following are 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, other instruments, or 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/split/protruding/partial separating of the tissue pad.In turn, the probe tip may break before displaying an error window or generating an alarm tone.During output, do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments.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, which may lead to burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure".Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN FINE JAW TYPE X
• 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: 17603513
• MDR Text Key: 321742131
• Report Number: 9614641-2023-01220
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170435829
• UDI-Public: 04953170435829
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0009OFX
• Device Lot Number: 33K14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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
• Treatment: ESG-400; TD-TB400; USG-400