MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 20 CM, INLINE GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0520IC
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reference device was returned to service center for an evaluation.The device was attached to the usg-400/esg-400 and a probe check was performed and the device passed the probe check.Both switches were checked and found both switches are functional.A visual inspection was performed on the returned device and found there tissues build up, consistent that the device was in use.The ptfe (teflon pad) was inspected and found some parts to be burned/melted and missing, exposing metal.Approximately 0.597¿ of metal is exposed and 0.301¿ of the teflon pad is missing/melted.U511 short circuit error observed when the probe and jaw are closed and activated, due to insufficient insulation from the burned teflon pad.The distal end of the device was inspected under a microscope and found the probe unit to be charred.Based on the evaluation, the reported complaint was confirmed.The teflon pad on the device is burned/melted, missing, exposing metal.The root cause of the reported complaint is likely due to mishandling.As a preventive measure, the instruction manual provides several warning statements in an effort to prevent damage to the probe."do not 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
Service center was informed that during a diagnostic, coag, sigmoid colectomy procedure the silicon layer on the jaws of the device melted.The device and associated equipment were inspected prior to use and no abnormalities observed.It was reported that generator setting was 1-1 and no error codes displayed on the generator when the event occurred.The procedure was completed using a similar device.There were no patient injury reported.

• Brand Name: THUNDERBEAT 5 MM, 20 CM, INLINE 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: 8837082
• Report Number: 8010047-2019-02725
• Device Sequence Number: 14141957
• Product Code: GEI
• UDI-Device Identifier: 04953170308710
• UDI-Public: 04953170308710
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K132703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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-0520IC
• Device Lot Number: 84K 24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1