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

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/21/2022

Event Type  malfunction  

Event Description

The user facility reported that a doctor 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.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris service technician arrived on site to inspect the lighting system and confirmed the shield had detached.Steris has provided the user facility with a quote to replace the harmony rshield radiation protection device.No additional issues have been reported.

• 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: 13545704
• MDR Text Key: 288482349
• Report Number: 1043572-2022-00014
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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: 01/21/2022
• 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