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 Problem Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility further reported that there was a delay in the procedure and the patient was under general anesthesia for an extra thirty minutes.The patient did not have any pre-existing conditions.Additionally, device was inspected prior to the procedure and no damage or abnormalities were noticed.There was no metal exposed on the jaw.The generator settings were normal.There were no error codes displayed in the generator.The connection points to the generator were inspected.There was no cable damage observed.The physician is experienced in using this device.There were no other devices involved in the event.The referenced device was returned to the service center for evaluation for the reported ¿probe tip snapped off¿.The device was attached to test usg-400/esg-400 generators and a probe check was performed; the device did not pass the probe check.The distal end of the device was inspected under a microscope and found the probe tip was broken and missing.The ptfe pad (teflon pad) was inspected and there is normal wear with no metal exposed and there was some tissue buildup on the jaw.Additionally, both switches were checked and both switches are functional.The wiper movement is normal.The consistency of movement of the handle and jaw was normal.The handle load was normal.The rotation of the knob torque was normal and smooth.The root cause of the reported event cannot be determined at this time as the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The service group was informed by the user facility that during the beginning of a procedure, the jaw was closed in order to be inserted through the working channel but when the user tried to open it inside the patient the probe tip snapped off in the patient's abdomen.The broken probe tip was retrieved with a laparoscopic grasper.The piece that fell into the patient was not sharp.No patient injury/death/or infection was reported.The doctor opened a new item of the same lot to complete the procedure with out issue.

Manufacturer Narrative

This supplemental report was submitted to provide additional information to mdr# 8010047-2020-03638.The original equipment manufacturer (oem), omsc, performed a device history record review and no abnormalities were noted.No device was returned to the oem, however, an investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined to be due to contact with a surgical instrument or the non-insulated area of grasping section.The detailed mechanisms are shown below.Contact with a surgical instrument: 1.During output in seal & cut mode, the probe came in contact with 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.3.The probe broke when added load.Contact with non-insulated area of grasping section: 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 of the grasping section to touch the probe.3.¿seal & cut¿ output was activated under this situation, then the scratches indicating that the probe and grasping section were in contact with each other were made.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.5.The probe broke when added load.The coating of the grasping section could have come off when dirt such as burn was scraped off with something hard.As a result of checking the instruction manual, the following descriptions related to this event were found.This event is warned by the instruction manual.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.If the grasping section, metal-exposed area around it or the probe tip gets sticked tissue during treatment, wipe it with a soft object such as a piece of gauze or a brush.Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure.

• 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
• MDR Report Key: 10196605
• MDR Text Key: 197646266
• Report Number: 8010047-2020-03638
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• PMA/PMN Number: K172610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: KR872724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 83