MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS THUNDERBEAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number TB0545FCS

Device Problems Break (1069); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

The thunderbeat handpiece used for dissection stopped working while in use times 2.When taken out of the patient and trying to clean and clear the error, one of the jaws broke off, each time.Two different handpieces, 2 failures, 2 different broken jaws.We were able to find all of the pieces.Fda safety report id# (b)(4).

• Brand Name: THUNDERBEAT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 15371218
• MDR Text Key: 299466373
• Report Number: MW5111889
• Device Sequence Number: 2
• Product Code: GEI
• 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: 09/01/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: TB0545FCS
• Device Lot Number: KR252685
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White