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

Model Number TB-0535FC

Device Problems Degraded (1153); Peeled/Delaminated (1454); Material Separation (1562); Material Integrity Problem (2978)

Patient Problems Laceration(s) (1946); Patient Problem/Medical Problem (2688)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Manufactured date of the device is not known at this time.A supplemental report will be filed as the information becomes available.This event has been reported by the importer on mdr# 2951238-2020-00346.

Event Description

User report stated that during a therapeutic total laparoscopic hysterectomy procedure the teflon pad peeled back leading to a laceration of the patient's bladder.There was no bleeding as a result of the injury.A urologist was called to repair the bladder.The patient was not admitted to the hospital for this injury and the patient¿s condition is stable.No additional devices were used as a result of this injury nor were additional medications required.The intended procedure was completed.

Manufacturer Narrative

Please see the updates in sections: d4 (lot #), d10, g4, g7, h2, h3, h4, h6 and h10.The device has been returned and a device evaluation is completed for it.The actual device lot # is kr866915.The user¿s complaint was confirmed.The teflon pad is found separated/lifting from the jaw; however, not detached from the device.The device was attached to the usg-400/esg-400 and a probe check was performed; the device passed the probe check.Both switches were checked and found both switches are functional.A visual inspection on the received condition was performed on the device; there is some tissue build up.The ptfe pad (teflon pad) was inspected and found it is separated from the jaw exposing metal.In addition, there is a small burn mark located at the middle section of the teflon pad.Although, the teflon pad has separated/lifted from the jaw, it is still intact to the distal end of the thunderbeat device.The distal end of the device was inspected under a microscope and found char marks throughout the probe unit, and some foreign material present.The wiper movement is normal.The consistency of movement of the handle and jaw is normal.The handle load is normal.The rotation of the knob torque is normal and smooth conclusion based on the evaluation is that the likely cause of the damaged teflon pad is due to no tissue or insufficient tissue between the probe and jaw during activation of the device.The instruction manual (ifu) includes several warning statements in an effort to prevent damage to the device: "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.¿.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• 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
• MDR Report Key: 9739836
• MDR Text Key: 195095592
• Report Number: 8010047-2020-01477
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170337574
• UDI-Public: 04953170337574
• Combination Product (y/n): N
• PMA/PMN Number: K111202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FC
• Device Lot Number: KR866915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/21/2020
• Supplement Dates Manufacturer Received: 02/28/2020
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 59