MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0520FCS

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was observed that during the device evaluation, the ultrasonic surgical device exhibited the probe falling (during wiping the probe outside of the body).There were no reports of patient involvement.

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: d4, e1 (telephone number should be blank) and h4.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation it is likely that the mechanism causing the breakage of the probe might be the following: 1) during the output activation in seal & cut mode, the distal end of the probe was slightly contacting a thin equipment, causing spark generation.2) a force was applied to the probe during spark generation.3) cracks occurred in the probe due to the load applied to the probe during tissue grasping and seal & cut output.Also, the probe damage error (u504) occurred.4) due to continuous use of the device, the cracks on the probe progressed.This led to breakage of the probe.However, the root cause was unable to be specified.The event can be prevented by following the instructions for use: ¿ 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, 20 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: 18989915
• MDR Text Key: 338766574
• Report Number: 9614641-2024-00776
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383588
• UDI-Public: 04953170383588
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TB-0520FCS
• Device Lot Number: 32K21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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: USG-400, ULTRASONIC GENERATOR