MAUDE Adverse Event Report: ONE DIVERSIFIED, LLC CORIS ; SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL

Catalog Number MD-02

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 02/05/2020

Event Type  Injury  

Event Description

On 02/05/2020, it was reported by a user facility that a medical device system installed in the operating suite, is potentially contributing to an increase in post-surgery infection rate due to the device location within the suite.The facility reported that infectious control conducted an investigation.The investigation revealed dust particles with the enclosure of the device system installed within the operating suites.Samples of the dust was analyzed by the facility and revealed similarities as the infections seen in pts.Fda safety report id # (b)(4).

• Brand Name: CORIS
• Type of Device: SYSTEM, DIGITAL IMAGE COMMUNICATIONS, RADIOLOGICAL
• Manufacturer (Section D): ONE DIVERSIFIED, LLC ; dallas TX 75229
• MDR Report Key: 9865219
• MDR Text Key: 184826508
• Report Number: MW5093872
• Device Sequence Number: 1
• Product Code: LMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MD-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other