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

Model Number TB-0535FC

Device Problem Flare or Flash (2942)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to olympus and an initial device inspection has been performed.The grasping surface of the shaft had tissue build up near the distal end, the polytetrafluoroethylene pad (teflon pad) was separated from the jaw exposing metal, and the middle portion of the teflon pad was partially split.The remainder of the device inspection determined all other components met specifications.The investigation is in process.A supplemental report will be submitted with device evaluation results.

Event Description

The user facility reported to olympus, the white wire started burning on the thunderbeat front-actuated grip, during a procedure on (b)(6) 2021.The procedure was completed using a similar device without any issues.It is unknown if the device was inspected prior to the procedure.No patient harm or injury was reported.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed all specifications were met.The reported event was confirmed, the tissue pad was peeled off.The exact cause of the reported event could not be identified.However, it is likely the probable cause of the peeling of the tissue pad might be the following: 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 and a part of it was torn.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.Instructions for use, warnings & cautions: do not activate output in seal & cut mode while the grasping section is closed without contacting tissue or vessel, or ensuring that tissue is transected.Otherwise, a local increase of the temperature due to a friction between the probe tip and the grasping section may result in various forms of damage in the probe tip and/or the tissue pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.When cutting and vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall off, and partial separating of the tissue pad may occur due to a local increase of temperature caused by the friction between tissue pad and the probe tip during activation.

• 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: 11897957
• MDR Text Key: 253057805
• Report Number: 8010047-2021-06817
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FC
• Device Lot Number: KR897637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: USG-400,ESG-400; USG-400,ESG-400