MAUDE Adverse Event Report: STERIS STERIS; OPERATING ROOM LIGHT

Model Number HARMONY, G5

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2017

Event Type  malfunction  

Event Description

The canopy and gasket that cover the ceiling mounting bracket for the operating room light came loose and fell out of place.The ceiling gasket actually fell into patient field, but did not actually come in contact with the pt.Pt was moved to another part of the room and later x-rayed to verify no debris was lost or left in pt field.The operating room light mfr was contacted and responded with opening an investigation as to cause and future preventions.

• Brand Name: STERIS
• Type of Device: OPERATING ROOM LIGHT
• Manufacturer (Section D): STERIS ; mentor OH 44060
• MDR Report Key: 6279057
• MDR Text Key: 65941426
• Report Number: MW5067475
• Device Sequence Number: 1
• Product Code: FSY
• 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: 01/20/2017

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
• Device Operator: Health Professional
• Device Model Number: HARMONY, G5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2017
• Type of Device Usage: N
• Patient Sequence Number: 1