MAUDE Adverse Event Report: U.S. SURGITECH INC. SURGYCUT; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	790-109-535
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We have had three different instances occur in the past week.The first one occurred on [date redacted], where the blue coating on the end melted off and we had to suction out small blue balls.The second instance occurred two days later, where the black coating peeled back off the hook.The third instance occurred today [four days after the 2nd event], where the black coating peeled off the l-hook wire electrode while the surgeon was using it.We do not have the lot number information for the third instance.

• Brand Name: SURGYCUT
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): U.S. SURGITECH INC.; 551 kimberly drive; carol stream IL 60188
• MDR Report Key: 20842158
• Report Number: 20842158
• Device Sequence Number: 17125994
• Product Code: GEI
• UDI-Device Identifier: 00810014631257
• UDI-Public: (01)00810014631257
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/25/2024
• Report Date (Section F): 11/25/2024

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
• Device Model Number: 790-109-535
• Device Catalogue Number: 790-109-535
• Device Lot Number: 20240405
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 12/04/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/25/2024