MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LB51 LIGHT HANDLE COVER

Model Number Lighthandle Cover

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Cardinal health medical products & services is the distributor of the lb51 light handle covers subject of the reported event.Cardinal health documentation has indicated that they utilized the steris lb55 packaging tray in the surgical pack associated with this complaint.This is not the packaging tray product recommended by steris for this application.Steris recommends the use of the lb52 packaging tray to maintain the shape of the bezel bowl during sterilization and the packaging process.Should steris's recommendations not be followed, deformation can result, leading to an unusable and/or contaminated product.The instructions for use states, "please note that bowl deformation may result in inadvertent contamination of the light handle cover.Steris recommends the use of a packaging tray (example shown at left) to maintain the shape of the bezel bowl during sterilization and the packaging process.The packaging tray is available for purchase from steris as equipment number lb52.".Cardinal health was counseled on the proper packaging protocols, specifically the use of the recommended packaging tray associated with the lb51 light handle covers.No additional issues have been reported.

Event Description

The user facility reported that they are receiving "misshaped" lb51 light handle covers that do not fit properly on the surgical lights causing them to fall into the sterile field.User facility personnel removed and replaced the fallen covers and reestablished the sterile field resulting in a procedure delay.No report of injury.

• Brand Name: LB51 LIGHT HANDLE COVER
• Type of Device: LIGHT HANDLE COVER
• 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
• MDR Report Key: 16999272
• MDR Text Key: 315925434
• Report Number: 1043572-2023-00109
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 50724995156386
• UDI-Public: 50724995156386
• 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: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Lighthandle Cover
• Device Catalogue Number: LB51
• Device Lot Number: 8851498
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1