MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. MEGADYNE FOOTSWITCHING SUCTION COAGULATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	004025
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the endoscopic sinus surgery, it was observed that insulation from magadyne disposable cautery left residual insulation in the patient when used.

• Brand Name: MEGADYNE FOOTSWITCHING SUCTION COAGULATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.
• MDR Report Key: 18650565
• Report Number: MW5151081
• Device Sequence Number: 20662195
• Product Code: GEI
• UDI-Device Identifier: 10614559105139
• UDI-Public: (01)10614559105139(17)280630(10)2307031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 004025
• Device Lot Number: 2307011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White