MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. 5MM, 35CM, FRONT-ACTUATED GRIP, TYPE S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number TB-0535FCS

Device Problem Material Integrity Problem (2978)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

The first thunderbeat opened for this case gave a probe damage error after 15 minutes of use.The olympus machine gave error message u504, probe damage error.Upon visual inspection the probe tip of the handpiece was intact.A new thunderbeat was opened.

• Brand Name: 5MM, 35CM, FRONT-ACTUATED GRIP, TYPE S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.
• MDR Report Key: 15906039
• MDR Text Key: 304867289
• Report Number: MW5113577
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/07/2022

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 Model Number: TB-0535FCS
• Device Lot Number: KR239766
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male