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

Lot Number KR222853

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Patient up from ed for a surgical procedure.Physician wanted to use the thunderbeat.Staff in operating room opened non disposable cord and disposable handpiece.Thunderbeat machine gave an error message.Called spd for another non disposable cord.Same error message came up.Did not open another disposable handpiece as the physician wanted to move along with the procedure.Collected the disposable handpiece and gave it to the coordinator of gyn procedures.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: 15027888
• MDR Text Key: 296059388
• Report Number: MW5110878
• 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: 07/12/2022

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
• Device Operator: Health Professional
• Device Lot Number: KR222853
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female