MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LB53 LIGHTHANDLE COVER; LIGHTHANDLE COVER TO HARMONY LIGHTING SYSTEM

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2019

Event Type  malfunction  

Manufacturer Narrative

User facility personnel immediately isolated the lighthandle cover and packaging; the cover did not enter the sterile field.The lighthandle cover is manufactured and packaged in a controlled environment.Employees wear hairnets, safety glasses, gloves, and are fully gowned.The lighthandle cover is terminally sterilized using ethylene oxide.The entire lighthandle cover device including the contents within the sterile barrier are considered sterile.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.There have been no other complaints associated with this lot.No additional issues have been reported.

Event Description

The user facility reported via medwatch report# (b)(4) that a hair was found within the packaging of a lighthandle cover prior to the start of a procedure.No report of injury or procedure delay.

• Brand Name: LB53 LIGHTHANDLE COVER
• Type of Device: LIGHTHANDLE COVER TO HARMONY 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: 8966232
• MDR Text Key: 209005178
• Report Number: 1043572-2019-00075
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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