MAUDE Adverse Event Report: I.C. MEDICAL, INC. ULTRA VAC E-Z CLEAN; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	211010EC
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A.Bovie made no noise, would not work so a new bovie was opened and worked fine.B.Bovie did not function properly- only the cut button worked when pressed and the coag button did not work at all.(no affected patient).C and d.Bovies would not work when plugged into bovie machine - buttons would not work.

• Brand Name: ULTRA VAC E-Z CLEAN
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): I.C. MEDICAL, INC.; 15002 north 25th drive; phoenix AZ 58023
• MDR Report Key: 9693570
• Report Number: 9693570
• Device Sequence Number: 1878092
• Product Code: GEI
• UDI-Device Identifier: 00817688022244
• UDI-Public: (01)00817688022244
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/14/2020
• Report Date (Section F): 01/15/2020

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 Model Number: 211010EC
• Device Catalogue Number: 211010EC
• Device Lot Number: 7787
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 86
• Date Report Sent to FDA: 01/15/2020