MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY M SERIES SURGICAL LIGHT

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/28/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived on-sit, inspected the lighthead, and identified a missing snap ring on the lighthead adapter.The technician replaced the lighthead and the lighthead adapter, tested the unit, and confirmed it to be operating according to specification.No additional issues have been reported.The harmony m series surgical light subject of the reported event is being returned to steris for evaluation.A follow-up mdr will be submitted if additional information is obtained.

Event Description

The user facility stated that their harmony m series surgical light was loose at the connection point between the lighthead and lighthead adapter.No injury, procedure delay, or cancellation was reported.

• Brand Name: HARMONY M SERIES SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• 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: 6113039
• MDR Text Key: 60750152
• Report Number: 1043572-2016-00092
• Device Sequence Number: 1
• Product Code: FSY
• 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
• Type of Report: Initial
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• 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: 10/28/2016
• 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