MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LIGHTING SYSTEM

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Steris has contacted the user facility requesting to perform an inspection of the lighting system and to obtain additional information regarding the reported event; however, to date the user facility has not responded.The user facility did not provide a model or serial number for the lighting system.A follow-up mdr will be submitted should additional information become available.

Event Description

The user facility reported that during a patient procedure one of the covers to their steris lighting system detached and fell onto the patient.No further information was provided regarding the patient or details of the event.

• Brand Name: LIGHTING SYSTEM
• Type of Device: 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 ; 4403927453
• MDR Report Key: 12975646
• MDR Text Key: 284830158
• Report Number: 1043572-2021-00087
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2021
• Initial Date FDA Received: 12/10/2021
• 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