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U.S. Department of Health and Human Services

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

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STERIS CORPORATION - MONTGOMERY HARMONY LIGHT HANDLE COVER Back to Search Results
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 Outdated item should not be used.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.
 
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Brand NameHARMONY LIGHT HANDLE COVER
Type of DeviceLIGHT 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 Key6576983
MDR Text Key75606764
Report Number1043572-2017-00028
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received05/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2017
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

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