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

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the user facility personnel opened and used an expired harmony light handle cover.The procedure was completed successfully.The user facility personnel did not properly inspect the light handle cover package to ensure that the item was suitable for use such as checking the labeled expiration date.The expired light handle cover was retrieved from the user facilities inventory.Perioperative standards and recommended practices include instruction for user facility's when using items within the sterile field, "if an expiration date is provided, the date should be checked before the package is opened and the contents delivered to the field.Outdated item should not be used." following the reported event, the user facility reviewed all light handle covers in inventory and disposed of any remaining expired light handle covers.New light covers were delivered to the user facility the next day.No additional issues have been reported.The account manager reiterated the importance of reviewing the light handle cover's expiration date before use in a patient procedure.

Event Description

The user reported that an expired harmony light handle cover was utilized during a patient procedure.No adverse effects were reported.No report of procedure delays or cancellations.

• Brand Name: HARMONY 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6576983
• MDR Text Key: 75606764
• Report Number: 1043572-2017-00028
• Device Sequence Number: 1
• Product Code: FTD
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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