MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number TB-0535FCS

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

Opened a thunderbeat device that had a hair inside the sterile manufacturers packaging.Was caught prior to placing on sterile field.

• Brand Name: THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; bartlett TN
• MDR Report Key: 16903405
• MDR Text Key: 315030964
• Report Number: MW5117428
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: TB-0535FCS
• Device Lot Number: PW308447
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female