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

Model Number	TB-0545FC
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined at this time; however, based on similar reports, this type of teflon pad damage is most likely related to the operator's technique.The instruction manual contains several warning statements in an effort to prevent damage to the teflon pad."do not to activate output in seal and cut mode while the grasping section is closed without contacting tissue or vessel.Do not activate output while applying the probe tip to the tissue with a strong force.Do not activate output while grasping thick and hard tissues.Otherwise, various forms of damage in the probe tip and/or the tissue pad such as premature wear, breakage, deformation, exposure of metal, and/or falling inside the body cavity, and/or partial separating may occur.".
Event or Problem Description
Olympus was informed that during a sleeve gastrectomy procedure, the teflon pad from the grasping section of the device burnt and peeled back exposing metal.It was reported that simultaneously, a "probe damage" error message was observed on the generator.The surgeon was performing the seal/cut function when the teflon pad damage occurred.There was no bleeding reported.No device fragment fell into the patient.The intended procedure was completed with a similar device.There was no patient injury reported.Additionally, the user facility reported that the device and the connection points were inspected prior to the procedure with no anomalies found.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results, correct the device lot number and manufacture date.The device was returned to olympus for evaluation.The user¿s complaint was not confirmed.A visual inspection was performed on the returned device and found some tissue build up.The ptfe pad (teflon pad) was inspected and found to have normal wear with no metal exposed.There were burnt marks also noted on the top portion of the upper device jaw.The distal end of the device was inspected under a microscope and found no visual indication of damage to the probe unit.Based on the investigation results, the device functioned as intended.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7716650
• Report Number: 2951238-2018-00425
• Device Sequence Number: 11011983
• Product Code: GEI
• UDI-Device Identifier: 04953170337543
• UDI-Public: 04953170337543
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: Health Professional
• Device Model Number: TB-0545FC
• Device Catalogue Number: TB-0545FC
• Device Lot Number: MK694761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1