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

Model Number	CDSH45D
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We found a bug in the pack (on lid of irrigation tub) before the patient was in the room, all set up was taken down and reset.The pack was cmc shoulder arthroscopy pack and the ref# (b)(4).I have the lid with the bug in my office for pick up.

• Brand Name: ACS
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): AMERICAN CONTRACT SYSTEMS; 7300 w detroit st; chandler AZ 85226
• MDR Report Key: 9779407
• Report Number: 9779407
• Device Sequence Number: 713783
• Product Code: LRO
• UDI-Device Identifier: 00191072046291
• UDI-Public: (01)00191072046291(17)201203(10)663191
• 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): 02/19/2020
• Report Date (Section F): 02/19/2020

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: CDSH45D
• Device Catalogue Number: CDSH45D
• Device Lot Number: 663191
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2020
• 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: 02/19/2020