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

Model Number G-Series Surgical Lighting System

Device Problem Flaked (1246)

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

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

A steris service technician inspected the surgical lighting system and found evidence of paint chipping and rust on the spring arm.Through follow-up, the steris technician learned that user facility personnel were not performing proper cleaning practices for the lighting system specifically using a chemical not approved for use on the equipment and/or properly drying the lighting system after cleaning activities.The operator manual states (section 6), "cleaning the equipment warning-risk of contamination and infection of patients: certain parts of the product are made of plastic.Solvents may dissolve plastic.Concentrated acids, caustic solutions and media with more than 60% alcohol may cause material embrittlement.Damaged parts may fall into open wounds.If cleaning fluid is allowed to penetrate the device, surplus cleaning caution-possible equipment damage: use of any disinfectant solution other than those listed here may cause discoloration or deformation on the system components." the operator manual further states, "the use of h2o2 + paa (hydrogen peroxide + peracetic acid) is strongly discouraged for use on all steris products.Always follow manufacturer instructions for concentrations and use of cleaning products.The following areas of the system must be cleaned and disinfected before each use of the lighthead.Suspension arm-wipe the entire suspension arm, including the suspension fork and yoke." the steris service technician and steris district service manager (dsm) stated that the user facility has multiple surgical lighting systems that exhibit paint chipping and rust.The surgical lighting systems are not under a steris service contract and are serviced and maintained by the user facility.The steris service technician and dsm counseled user facility personnel on the importance of conducting proper cleaning practices on their steris surgical lighting systems.The user facility elected to service and perform repair activity for their lighting systems.

Event Description

The user facility reported that during a patient procedure a paint chip from their harmonyair g-series surgical lighting system fell into the sterile field.User facility personnel reestablished the sterile field subsequently causing a procedure delay; the patient procedure was completed successfully.No report of injury.

• Brand Name: HARMONYAIR G-SERIES SURGICAL 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: 15988373
• MDR Text Key: 306519459
• Report Number: 1043572-2022-00089
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 00724995192457
• UDI-Public: 00724995192457
• 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: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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: LGH51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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