MAUDE Adverse Event Report: AMERICAN CONTRACT SYSTEMS, INC. ACS; GENERAL SURGERY TRAY

Model Number	CDEX31D
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During case set up the asepto in the extremity pack had an unknown substance on it.The pack and all instruments were removed.New set up started.Patient was not in the room.Pack saved.

• Brand Name: ACS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS, INC.; 7802 e telecom pkwy; tampa FL 33637
• MDR Report Key: 9081665
• Report Number: 9081665
• Device Sequence Number: 2623078
• Product Code: LRO
• UDI-Device Identifier: 00191072046109
• UDI-Public: (01)00191072046109(17)200608(10)41191
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/21/2019
• Report Date (Section F): 08/21/2019

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: CDEX31D
• Device Lot Number: 41191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 125
• Date Report Sent to FDA: 08/21/2019