MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0520FCS

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

It was reported during a gastrectomy therapeutic procedure, with the functional setting of seal&cut mode 1, the portion of ptfe pad partially split in cross direction with ptfe pad burning with probe damage error occurred.The spilt portion was found not totally separated from the upper -jaw on the tip and did not fall in 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

The subject device was received and evaluated.The subject product name was tb-0520fcs.The lot no.Was 1zk, supplemental information 03.The subject device was manufactured on 03 dec,2021.Based on the service business center olympus korea (sbc okr), 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, and 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.The thunderbeat instrument should be used for soft tissue.Do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such as metal clips, stapler, other instruments, or forceps, and others.Otherwise, it may cause the probe tip to be scratched or come into direct contact with the metal area of the grasping section as the heat generated by the friction between the hard object and the probe tip could cause wear/deforming/split/protruding/partial separating of the tissue pad.In turn, the probe tip may break before displaying an error window or generating an alarm tone.Do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities.Based on investigation results in the past, a likely 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.Based on investigation results in the past, a likely mechanism causing probe damage error might be the following: contact with a surgical instrument, hard tissue, a metal object or a surgical instrument had been in contact with the probe during the output activation in seal & cut mode causing the scratches on the probe.In addition, the probe was applied load and a probe damage error detected.Contact with non-insulated area of grasping section.Grasping section was closed without grasping anything while the device was activating in seal & cut mode (this includes after tissue resection) causing the tissue pad to wear out.Since the tissue pad worn out, non-insulated area of the grasping section and the distal end of the probe came into contact.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing probe damage error.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report is being submitted to correct section b5 from the initial report with the following information: the intended procedure was completed with a similar set of equipment is being corrected to "the intended procedure was completed by replacing the device and completed with the same set of equipment".

Event Description

The intended procedure was completed by replacing the device with the same set of equipment.

• Brand Name: THUNDERBEAT 5 MM, 20 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: 15317796
• MDR Text Key: 305536283
• Report Number: 9614641-2022-00229
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383588
• UDI-Public: 04953170383588
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0520FCS
• Device Lot Number: 1ZK03
• 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
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 08/30/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2021
• 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