MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LED 585 SURGICAL LIGHT; SURGICAL LIGHTING SYSTEM

Device Problems Image Display Error/Artifact (1304); Loss of Power (1475)

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

Event Date 07/13/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the surgical lighting system, and identified a switch wire was pinched between the aluminum hub base and the plastic camera mount.An abrasion was observed on the wire's sheathing (insulation) from the pinched area.This abrasion would cause an intermittent short in the wire.The technician repaired the sheathing (insulation) around the outside of the wire and relocated the wire to a position in which it would not be at risk of being pinched.The wire itself was not damaged and did not require replacement.The unit was tested, confirmed operational, and returned to service.No additional issues have been reported.

Event Description

The user facility reported during a patient procedure the camera lighthead on their harmony led 585 surgical lighting system would dim or would turn off completely when the lighthead was adjusted.The user facility was able to restore the light to full illumination after each occurrence.No report of injury or procedural delay or cancellation.

• Brand Name: HARMONY LED 585 SURGICAL LIGHT
• Type of Device: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4973675
• MDR Text Key: 23947032
• Report Number: 1043572-2015-00073
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1