MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM

Model Number G-SERIES SURGICAL LIGHTING SYSTEM

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

A steris service technician inspected the surgical lighting system and found that the tension of the lighthead spring arm required adjustment.As the tension of the lighthead spring arm required adjustment, this allowed the spring arm to drift slowing downwards in height subsequently causing the reported event to occur.The technician adjusted the spring arm tension, tested the surgical lighting system and confirmed the unit to be operational.The device was returned to service and no additional issues have been reported.

Event Description

The user facility reported that the lighthead from their harmonyair g-series surgical lighting system came down and "struck" an employee's head.No report of injury.No medical treatment was sought or administered.

• Brand Name: HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM
• 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: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 17135919
• MDR Text Key: 317241985
• Report Number: 1043572-2023-00115
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995191979
• UDI-Public: 00724995191979
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LG07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• 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