MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY VLED DUAL SURGICAL LIGHT

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

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

Event Date 03/06/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure a plastic cover detached from the supporting spring arm of a harmony vled surgical light.The cover fell on the sterile draping covering the lower half of the patient.The or staff removed the cover and impacted sterile draping.The draping was replaced and the procedure was completed successfully.No injuries to hospital staff or patient reported.No procedural cancellations were reported.

Manufacturer Narrative

A steris service technician inspected the surgical light and found the unit was missing the round covers on the spring arm.The covers are integral to the mounting/securement of the spring arm side covers.The absence of these covers caused the arm cover to detach and fall.The spring arm was installed in a retro-fit activity for the surgical light and not installed originally with the surgical light.Due to this activity, the steris technician believes the missing covers were not installed due to the installer lacking the knowledge that the covers were required for the correct installation of the spring arms.The technician ordered the necessary round covers to repair the light.Steris dsm discussed the proper installation procedures with the technician(s).

Manufacturer Narrative

The steris technician received the necessary parts to repair the light.He installed the covers and screws on the spring arm and confirmed the light to be operational; no further issues have been reported.

• Brand Name: HARMONY VLED DUAL 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: 3726729
• MDR Text Key: 4323127
• Report Number: 1043572-2014-00028
• Device Sequence Number: 1
• Product Code: FST
• 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: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• 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: 03/06/2014
• 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