MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT TRANSDUCER

Model Number	TD-TB400
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.If additional information becomes available at a later time, this report will be supplemented.
Event or Problem Description
Device 3 of 3.It was reported that during a liver resection procedure, the tissue pads of both handles of the device melted.A different device was used to complete the procedure.No patient injury or harm occurred.It was noted the device was inspected prior to use.
Additional Manufacturer Narrative
Additional information has been received for this event.Also, the device has not been returned, as such, an actual device evaluation cannot be done.Device evaluation is performed by historical data and communication.This supplemental report is being submitted to provide this information.The serial number of the device is unknown.The device is not returned as it was not considered necessary as no specific issues found with the device.This device was not replaced during the procedure.Since the device serial number of the device is unknown, the device history record (dhr) for over the past year prior to the date of occurrence were reviewed.No abnormalities found from the dhr of the following items which relate to the reported phenomenon: ·seal & cut mode output, ·seal mode output, ·(continuity inspection) conduction, ·(operation check) ultrasonic oscillation, according to the information provided from the initiator, there were no abnormalities in the td-tb400, and it was able to use without any problems.Therefore, the device was not sent back for investigation.The phenomenon that the device causes severe abrasions (melting) of the tissue pad could not be confirmed.The instructions for use for the tb-0535fcs (used with the device) 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.¿ if the grasping section, metal-exposed area around it or the probe tip gets stuck 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 TRANSDUCER
• Common Device Name: TRANSDUCER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10343793
• Report Number: 8010047-2020-05025
• Device Sequence Number: 19645036
• Product Code: GEI
• UDI-Device Identifier: 04953170306778
• UDI-Public: 04953170306778
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: TD-TB400
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TB-0535FCS SERIAL (B)(6); TB-0535FCS SERIAL (B)(6); TB-0535FCS SERIAL KR910812; TB-0535FCS SERIAL KR912106
• Patient Age: 6 WK