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	Excessive Heating (4030)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was not yet been received for evaluation.The cause of the reported event cannot be determined.A supplemental report will be filed if and when the product is returned and investigation has been completed.As a preventive measure, the instruction manual states: to prevent injury to the surgeon, surgical staff, and/or patient due to accidental activation, do not leave the thunderbeat in contact with the patient or a flammable object, such as a drape, while not in use.Also, do not leave the instrument in contact with tissue, the patient, or a flammable object, such as a drape, after the output has ceased.Otherwise, unintentional burns of the surgeon, surgical staff, and/or patient, or a fire hazard may result.
Event or Problem Description
It was reported that the doctor used the thunderbeat tb-0545fc and laid it down on a drape.It was reported that the tip burned a hole on the drape and the doctor wanted the tip to be inspected.Field representative stated that the doctor was very experienced in using the thunderbeat.There was no patient/user injury was reported.
Additional Manufacturer Narrative
The returned tb-0545fc (lot#pw305155) was evaluated for ¿thunderbeat tip burned hole in a drape¿ issue.The reported complaint was not confirmed.Visual inspection noted that the device attached to the usg-400/esg-400.Probe check was performed and the device passed the probe check testing.Both switches were checked and found to be functional.In addition, visual inspection on the received condition was performed on the device and determined that there is some tissue buildup.The ptfe pad (teflon pad) was inspected and found it has normal wear, no abnormality and no metal exposure.The distal end of the device was inspected under a microscope and found no visual indication of damage to the probe unit.The wiper movement is noted to be normal and the consistency of movement of the handle and jaw is normal as well as the handle load.The rotation of the knob torque is determined to be normal and smooth.In addition, the device was left powered on for a total of 20 minutes, and the probe tip was touched by hand.The tip did not feel hot.Based on the evaluation, it was observed that the device has foreign material (tissue) on the distal end, which would imply that the thunderbeat has been used.It is likely possible that the device may have been placed onto the drape (as stated on the reported event) shortly after use, and the probe might have still been hot after procedure.As what the ifu (instruction for use) states ¿to prevent injury to the surgeon, surgical staff, and/or patient due to accidental activation, do not leave the thunderbeat in contact with the patient or a flammable object, such as a drape, while not in use.Also, do not leave the instrument in contact with tissue, the patient, or a flammable object, such as a drape, after the output has ceased.Otherwise, unintentional burns of the surgeon, surgical staff, and/or patient, or a fire hazard may result.In summary, based on evaluation, the reported issue was not duplicated.No issue was found and the device passed all the testing criteria.Reported issue was not confirmed.

• 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: 9204214
• Report Number: 8010047-2019-03625
• Device Sequence Number: 11520857
• Product Code: GEI
• UDI-Device Identifier: 04953170337543
• UDI-Public: 04953170337543
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 10/25/2019

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: No Information
• Device Model Number: TB-0545FC
• Device Lot Number: PW305156
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1