MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the service center followed up with the customer regarding the reported event and was informed that post procedure an olympus sales representative inspected the devices and found no visual damage to the teflon pad or probe unit.The sales representative checked the error codes on the customer¿s generation.It is believed that the connection points to the generator were inspected by the sales representative.There was no cable damage observed.The transducer cords or the cords to another medical device were not bundled during use.No device fragment fell inside the patient.The first device lot# kr107587 was returned to the service center for evaluation.The device was attached to our test usg-400/esg-400 and a probe check was performed; the device passed the probe check.Both switches were found to be functional.A visual inspection on the received condition was performed on the device; foreign material observed at the distal end, consistent with use.The ptfe pad (teflon pad) was inspected and found worn and lifted, with metal exposed.The distal end of the probe was inspected under a microscope and found no visual indication of damage to the probe unit.The wiper movement is not smooth due to foreign material.The consistency of the movement of the handle and jaw is also not smooth due to foreign material.The handle load is normal.The rotation of the knob torque is normal and smooth.The customer did not return the transducer used with the device for evaluation.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The device history record of osta for the lot indicated no anomaly with the event-related items below.The exact cause of the event couldn¿t be exclusively identified.However based on the investigation photos attached by the service center and past investigation results, the activation failure possibly occurred due to an error that caused was by contact with a surgical instrument or the non-insulated area of grasping section.The detailed mechanisms are shown below.Contact with a surgical instrument: 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 error occurred.Contact with non-insulated area of grasping section: the distal end of the tissue pad was worn away because ¿seal & cut¿ output was activated while grasping nothing (including the case the user kept activating after cutting tissue).The tissue pad was worn away, causing the non-insulated of the grasping section to touch the probe.¿seal & cut¿ output was activated under this situation, then the scratches indicating that the probe and grasping section were in contact with each other were made, and the error occurred.The peeling of the tissue pad was likely caused by the following mechanism: the tissue pad was worn away because no tissue was being grasped between the grasping section and the probe tip when the device was activated output in seal & cut mode for/after a transection of tissue.The tissue pad was excessively heated due to friction between the grasping section and the probe tip.This caused the tissue pad to be partially peeled away.Peel-off of the probe coating: it was confirmed that the probe coating was peeled off if the device was handled as follows.However, it could not be conclusively determined if such handling actually caused the reported phenomenon.Activate the device in seal and cut mode for a long duration while no tissue is grasped by the grasping section and the distal end of the probe.Activation in seal & cut mode continued after completion of a tissue cutting is also included in such activation.The instruction manual contains several warning statements in an effort to prevent damage to the teflon pad."do not to activate output in seal and cut mode while the grasping section is closed without contacting tissue or vessel.Do not activate output while applying the probe tip to the tissue with a strong force.Do not activate output while grasping thick and hard tissues.Otherwise, various forms of damage in the probe tip and/or the tissue pad such as premature wear, breakage, deformation, exposure of metal, and/or falling inside the body cavity, and/or partial separating may occur.".

Event Description

The service center was informed during a therapeutic laparoscopic hysterectomy procedure, two handpieces failed to exhibit output.The doctor changed out the transducer cord after the second hand piece was replaced and still no output was observed.The doctor was performing a cut/coag when the phenomenon occurred.A third device was used and the intended procedure was completed with no further issue.There were no other devices replaced during the procedure.The generator settings were unknown.The procedure was delayed approximately 60 minutes.There was no patient injury reported.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11265326
• MDR Text Key: 243854688
• Report Number: 8010047-2021-02129
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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: KR107587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• 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