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 Codes	Crack (1135); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.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 therapeutic total laparoscopic hysterectomy (tlh) procedure, the teflon pad from the grasping section of the device was peeling and the probe unit cracked.It was reported that surgeon was performing a seal/cut on the patient¿s tissue, when a ¿probe damage¿ error message was observed on the generator.The generator settings were 2 cut/1 coag.No device fragment fell into the patient.There was no bleeding observed.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 generator connection points were inspected prior to the procedure with no anomalies found.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 8238510
• Report Number: 2951238-2019-00354
• Device Sequence Number: 13848784
• Product Code: GEI
• UDI-Device Identifier: 04953170337543
• UDI-Public: 04953170337543
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 01/10/2019

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-0545FC
• Device Lot Number: PW305093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1