MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS ESG-400; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WB91051W

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 11/21/2023

Event Type  Injury  

Event Description

Patient burn to grounding pad site during use of cautery.Reference report mw5148993.

• Brand Name: OLYMPUS ESG-400
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 18290531
• MDR Text Key: 330157315
• Report Number: MW5148992
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: WB91051W
• Device Lot Number: B006354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 87 KG
• Patient Ethnicity: Hispanic