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 Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device referenced in this report has not yet been 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 a sleeve gastrectomy, the subject device was used.In the procedure, the tissue pad of the subject device was peeled off.The intended procedure was completed with similar device.There was no patient injury reported.This is the report regarding the peeled off 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.The lot number of the subject device is unknown.As a result of checking the manufacturing record for past six months from the delivery date, it was found no irregularities.Therefore, the exact cause of the reported event could not be conclusively determined.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 instruction manual of the device has already warned 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, 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
• MDR Report Key: 7817256
• Report Number: 8010047-2018-01648
• Device Sequence Number: 1287291
• Product Code: GEI
• UDI-Device Identifier: 04953170383526
• UDI-Public: 04953170383526
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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-0545FCS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1