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

Catalog Number TB-0535FCS

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Three thunderbeat devices opened and all three malfunctioned during use.One of the devices jaw broke off.No retained foreign object and no patient harm.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: 15744503
• MDR Text Key: 303278544
• Report Number: MW5113098
• Device Sequence Number: 1
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TB-0535FCS
• Device Lot Number: KR239745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1