MAUDE Adverse Event Report: CONMED CORPORATION ABC PROBE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 60-7500-120

Device Problem Melted (1385)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

During argon coagulation of l (left) renal mass site, the surgeon noted additional char sites on the exterior of the kidney (cortex).When inspected the argon beam handle was melted through and burning kidney at an unintended place.

• Brand Name: ABC PROBE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; largo FL 33773
• MDR Report Key: 16399298
• MDR Text Key: 309892985
• Report Number: MW5115028
• 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: 02/15/2023

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: 60-7500-120
• Device Catalogue Number: 160656
• Device Lot Number: 202207134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female