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	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.
Event or Problem Description
During an open hysterectomy and a lymph node dissection, the subject device was used.The seal & cut short circuit error occurred.The tissue pad of the subject device was severely worn and partially separated.The intended procedure was completed with another device.There was no patient injury reported.This is the report regarding the severely worn tissue pad and the separation of the tissue pad.
Additional Manufacturer Narrative
This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past three months from the event date, it was found no irregularities.Based on the past similar cases, omsc presumes 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 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: 8751887
• Report Number: 8010047-2019-02400
• Device Sequence Number: 1998833
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: Health Professional
• Device Model Number: TB-0520FCX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1