MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY LA 700 SURGICAL LIGHT; SURGICAL LAMP

Device Problems Loss of Power (1475); Device Stops Intermittently (1599)

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

Event Date 08/18/2015

Event Type  No Answer Provided  

Manufacturer Narrative

In addition to the intermittent camera issue, the user facility reported only a black and white image displayed on their monitor as opposed to the regular full color image.A steris field service technician arrived onsite, inspected the unit, and identified the hd knuckle and spindle commutators required replacement.The technician replaced the surgical light's hd knuckle and spindle commutators to address the signal issues with the camera.Additionally the technician replaced the hd lighthead harness and the full color was restored to the image.The technician tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported the in-light camera shut off intermittently during a patient procedure.The procedure was completed successfully.No report of injury or procedural delay or cancellation.

• Brand Name: HARMONY LA 700 SURGICAL LIGHT
• Type of Device: SURGICAL LAMP
• 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: 5078274
• MDR Text Key: 26317457
• Report Number: 1043572-2015-00085
• 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: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• 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: 08/19/2015
• 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