MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.An investigation has been opened to manage the actions related to remediation of this issue and any required mdr reporting.Additional information is not yet available for this event.The device was returned for evaluation of teflon coating had broken off into the patient and retrieved.The teflon pad of the device was intact, however, the probe piece was detached.The device was attached to the usg-400/esg-400 and a probe check was performed; the device failed the probe check with error code u509.Both switches were checked and found both switches are functional.A visual inspection on the received condition was performed on the device; there is some tissue build up located near the distal end.The ptfe pad (teflon pad) was inspected and found it has normal wear, no metal exposed, no abnormality and no missing portions.The distal end of the device was inspected under a microscope and found the probe is detached, missing portion returned for evaluation.The detached probe has signs of char marks as well as foreign residue stained on the probe.The returned detached probe measured at approximately 15.44 mm.The wiper movement is normal.The consistency of movement of the handle and jaw is normal.The handle load is normal.The rotation of the knob torque is normal and smooth.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant additional information is available.
Event or Problem Description
As reported for this event, during an unknown procedure the device teflon coating broke off into the patient and was retrieved.There is no harm or adverse impact to the patient.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, h4, h6, and h10.The device history record review confirmed that the device lot had no anomaly in inspection.The exact cause of the event cannot be exclusively identified.However based on past investigations, the broken probe possibly occurred due to contact with a surgical instrument or the non-insulated area of grasping section.The detailed step-by-step scenario is 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 with 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.The instructions for use includes the following statements: 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.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• Common Device Name: 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: 11886487
• Report Number: 8010047-2021-06762
• Device Sequence Number: 16497225
• Product Code: GEI
• UDI-Device Identifier: 04953170409684
• UDI-Public: 04953170409684
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K172610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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
• Operator of Device: Health Professional
• Device Model Number: TB-0545FCS
• Device Lot Number: KR108276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1