MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY RSHIELD RADIATION PROTECTION DEVICE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the lighting system and confirmed the shield had detached. The lighting system was installed in 2013 making it approximately 7 years old and is not under steris service agreement; the user facility is responsible for all maintenance activities. The technician reattached the radiation shield, tested the lighting system, confirmed it to be operating according to specification, and returned it to service. A 3-year complaint review indicates this to be an isolated event. No additional issues have been reported.

Event Description

The user facility reported that as an employee attempted to move the harmony rshield radiation protection device attached to their harmony led surgical lighting system, the shield subsequently detached from the lighting system. The employee caught the shield as it detached. No report of injury.

• Brand Name: HARMONY RSHIELD RADIATION PROTECTION DEVICE
• Type of Device: SHIELD
• 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 ; 4403927453
• MDR Report Key: 11079396
• MDR Text Key: 224759516
• Report Number: 1043572-2020-00067
• Device Sequence Number: 1
• Product Code: KPY
• 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: 12/28/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/02/2020
• 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