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

Model Number TB-0535FC

Device Problem Break (1069)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the front-actuated grip¿s gripping portion(tip of the jaw) broke off when removing from packaging during pre-use inspection.There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: b5, h8, h6 (health effect-impact code).The customer's complaint/reportable malfunction was 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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.However, the complaint information tab shows that the tissue pad is slightly worn, suggesting that the tb-0535fc was used in surgery and the grasping section was broken during surgery.A likely reason for the falling of the grasping section might be the following: 1.An excessive force in the direction for opening was applied to the grasping section.This caused the grasping section to detach from the shaft.2.Since a force in the twist direction was applied to the detached grasping section, the distal end of the inner pipe broke.As a result, the grasping section fell off.The event can be prevented by following the instructions for use which state: "when inserting and pulling out the thunder beat handle into the trocar mantle tube, lightly grasp the movable handle and make sure the grip is closed.Inserting or withdrawing the probe with the grip part open may damage the grip part or the tip of the probe, making it impossible to remove it from the trocar mantle.In the unlikely event that there are cracks, scratches, cracks, deformation, hangnails, protrusions, etc.On the probe tip, gripping section, insertion section, transducer exterior, transducer cord, transducer plug, etc., it may indicate abnormal output or high frequency leakage.Never use the device and replace it with a new spare device, as this may cause burns from the electric current or the probe tip falling off." olympus will continue to monitor field performance for this device.

Event Description

It was reported that during preparation for an unknown therapeutic procedure, the tip of the jaw on the thunderbeat grip device was found to be broken inside the packaging.The device was not used on the patient, and no parts fell into or outside of the patient.The intended procedure was completed successfully by using the conventional monopolar method of the hospital without delay.The patient's condition was not affected by the failure.There was no harm to the patient, and no medical intervention was required.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• 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: 18920965
• MDR Text Key: 337868112
• Report Number: 9614641-2024-00700
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170337574
• UDI-Public: 04953170337574
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K111202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TB-0535FC
• Device Lot Number: 82K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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