MAUDE Adverse Event Report: OLYMPUS THUNDERBEAT

Model Number TB-0535FC

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

Olympus thunderbeat hand piece stopped functioning.Displayed "probe damaged" while in use.Replaced with "like" device that functioned without incident for the remainder of the procedure.

• Brand Name: THUNDERBEAT
• Type of Device: THUNDERBEAT
• Manufacturer (Section D): OLYMPUS; center valley PA 18034
• MDR Report Key: 7048375
• MDR Text Key: 92726678
• Report Number: MW5073442
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: TB-0535FC
• Device Catalogue Number: TB-0535FC
• Device Lot Number: MK672687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR