MAUDE Adverse Event Report: NOVO HEALTH SERVICES, LLC; GENERAL SURGERY TRAY

Model Number	127566
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The double basin had two little holes in the green drape around them.The basin was immediately removed from back table and all the items around it.

• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): NOVO HEALTH SERVICES, LLC; 5155 westpark dr sw; atlanta GA 30336
• MDR Report Key: 8088992
• Report Number: 8088992
• Device Sequence Number: 16503153
• Product Code: KKX
• UDI-Device Identifier: 00812564035226
• UDI-Public: (01)00812564035226(11)181024(10)600752001
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/13/2018
• Report Date (Section F): 11/13/2018

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: Other
• Device Model Number: 127566
• Device Catalogue Number: 127566A
• Device Lot Number: 600752001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/13/2018