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 Problems Break (1069); Device Fell (4014)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.During evaluation it was observed, the probe broke 15 mm from the tip, there was a scratch around the broken part of the probe, cracks were noted from the scratches, tissue pad was noted to be worn, there was a mark of contact with the rear end of the probe on the non-insulated part.A review of the device history record found no deviations that could have caused or contributed to the reported issue.During investigation it was observed, the probe was broken at 15 mm from its distal end, there were contact marks on the probe.This indicates that the probe was in contact with the non-insulated area.Upon inspection of surface of the broken area, it was discovered that breakage of the probe started at the scratched area.Based on the results of the investigation, it is likely that the following led to the malfunction: 1.The seal & cut output was activated while the distal end of the grasping section was grasping thick tissues.2.The probe was in contact with the tissue pad at the rear end of the non-insulated of grasping section, causing the tissue pad to wear out.Also, it generated contact marks.3.The output was continuously activated in state of above description 2, and a force was applied to the probe, causing the probe to crack.4.A load was applied to the probe and it broke.The event can be detected/prevented by following the instructions for use which state: ¿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.During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or twisting the handle.Also, do not insert the handle while the handle is twisted with respect to the tissue, do not grasp it, and do not activate the output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.¿ olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, at the beginning of a total laparoscopic hysterectomy procedure, the probe of the thunderbeat 5 mm, 35 cm, front-actuated grip type s fell into the abdominal cavity.It was noted, all the dropped pieces have been collected.Subsequently, the procedure was completed by switching to a similar product.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This supplemental report is to provide additional information, please refer to section e1, e2, and e3.

• 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: 14776997
• MDR Text Key: 303149472
• Report Number: 8010047-2022-10556
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• 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: 21K-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2022
• 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