MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE X; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0520FCX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
Event or Problem Description
During an open surgery of partial hepatectomy, three thunderbeat devices were used.When the first thunderbeat device was being used, probe damage error occurred.About 3 hours after the start of procedure, the tissue pad was severely worn.The user exchanged the device to the second thunderbeat device and probe damage error occurred.About 1 hour after use, the tissue pad was severely worn.The intended procedure was completed with the third thunderbeat device.There was no patient injury reported.This is the report regarding the severely worn tissue pad of the first device.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc), but omsc could not evaluate the subject device since the device was used for a patient with an infection.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the tissue pad was damaged since the user continued to activate output without grasping tissue (including after the tissue already cut).The above device handling has been warned in the instruction manual as follows; 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.

• Brand Name: THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE X
• 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: 8923984
• Report Number: 8010047-2019-03013
• Device Sequence Number: 11294703
• Product Code: GEI
• UDI-Device Identifier: 04953170392238
• UDI-Public: 04953170392238
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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: No Information
• Device Model Number: TB-0520FCX
• Device Lot Number: 91K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1