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 Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  Injury  

Event Description

An olympus sales representative reported on behalf of a customer, during a hysterectomy, the thunderbeat experienced a breakage of the active blade within 10 to 15 minutes of use.The normal duration of the procedure was 90 minutes due to the incident, with an additional 10-15 minutes.The therapeutic total hysterectomy was completed using another similar device.There was no report of patient harm or injury associated with this event.Usage of subject device the usg-400 (ultrasonic generator) software version was 2.00.The setting of itm (intelligent tissue monitoring) ¿on¿ when the thunderbeat was used.In the hospital, the setting of itm is usually ¿on¿ when the thunderbeat was used.The user understood characteristics of itm functionality.The user did not change the itm setting during the procedure.

Manufacturer Narrative

The device was not kept for evaluation.Customer provided pictures of the following error codes: u504 (probe damage), u509 (ultrasonic level), and u514 (seal incomplete).Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information received.Updated fields: b1, b2, b5, e1, h1, h6.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus further received information that the falling part (probe) was not recovered from the patient's body.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the root cause could not be determined, however, the probe damage was likely caused by the following mechanisms: mechanism #1: 1.During output in seal & cut mode, the probe encountered hard tissue, metal, or a surgical instrument.Consequently, a scratch was made on the probe.2.The probe received an output load in seal & cut mode or received a load when grasping tissue.As a result, the probe cracked from the scratch causing the probe damage error and the ultrasonic level error.3.A load was added causing the probe to break.Mechanism #2 1.The distal end of the tissue pad was worn away because seal & cut output was activated while grasping nothing (including the case the user kept activating after cutting tissue).2.The tissue pad was worn away, causing the non-insulated area of the grasping section to touch the probe.3.Seal & cut output was activated under this situation, and the device was scratched (indicating that the probe and grasping section were in contact with each other).4.The probe received an output load in seal & cut mode or received a load when grasping tissue.As a result, the probe cracked from the scratch causing the probe damage error and the ultrasonic level error.5.A load was added causing the probe to break.The event can be detected/prevented by following the instructions for use (ifu) 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.¿ ¿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, or other instruments (e.G., uterine manipulator, 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/splitting/protruding/partial separating of the tissue pad.In turn, the probe 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.¿ ¿do not use the thunderbeat to seal a blood vessel with a diameter over 7 mm.Otherwise, sufficient sealing may not be achieved.¿ ¿even when using this instrument on blood vessel(s) with diameter of 7 mm or less depending on the condition of the patient or the blood vessel(s) and usage of thunderbeat, coagulation or sealing by the instrument could be insufficient, and patient bleeding may result.When using this instrument on blood vessel(s) with a diameter over 4 mm, be careful to avoid rebleeding.The recommended output setting for the seal & cut mode is level 1, and/or the recommended output setting for the seal mode is level 3.¿ ¿when treating a blood vessel and/or tissue, squeeze the control handle firmly until the control handle touches the grip handle to stop.Otherwise, incomplete sealing may cause bleeding.¿ ¿always position a vessel in the middle of the grasping section.Otherwise, the coagulation may be incomplete and the thunderbeat may wear out prematurely.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's updated investigation.Based in the results of the investigation, it is likely the probe broken which led to the probe residue could have occurred due to contact with a surgical instrument or the non-insulated area of grasping section.The detailed mechanism are listed in the previous supplemental report.Additionally, the root cause of the reported event could not be determined.

• 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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18052423
• MDR Text Key: 327269744
• Report Number: 9614641-2023-01645
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383557
• UDI-Public: 04953170383557
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: KR335865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2023
• 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 Outcome(s): Other