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

Model Number TB-0535FCS

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

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

Event Date 07/22/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.The subject product name was tb-0535fcs.The lot no.Was 22k, supplemental information 28.Based on the service business center olympus korea (sbc okr) device evaluation, it was confirmed that the tissue pad was severely worn.The dhrs (device history records) for this product have been reviewed.No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon.Process inspection slip.Quality inspection slip.Non-conforming product processing table.Review of the instruction for use (ifu) the following descriptions related to this event were found.The device's instruction manual provides the following warnings which may help / prevent the issue: 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 it is 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.Based on evaluation results , a likely mechanism causing the tissue pad severely worn out might be the following: nothing was grasped between the grasping section and the distal end of the probe while the output was activated in seal & cut mode (this includes after tissue resection).This caused the tissue pad to wear out severely.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during a hysterectomy therapeutic procedure, with the functional setting of seal & cut mode 3, the part of ptfe pad found burned out and slightly separated from the upper jaw.The detached portion was found not totally separated from the upper jaw and did not fall into the patient body.The intended procedure was completed with a similar set of equipment.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.Olympus will continue to monitor the performance of this device.

• Brand Name: THUNDERBEAT 5 MM, 35 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15324586
• MDR Text Key: 305508244
• Report Number: 9614641-2022-00234
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383557
• UDI-Public: 04953170383557
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• 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: 22K28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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
• Patient Sex: Prefer Not To Disclose