MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY LB54 LIGHTHANDLE CAMERA COVER

Device Problem Component Missing (2306)

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

Event Date 03/27/2020

Event Type  malfunction  

Manufacturer Narrative

Steris became aware of this event on october 8, 2020 through our periodic review of the (b)(4) database.The report did not identify the name or location of the user facility of the device in question.To-date we have not been informed of this event directly from the user facility.We will fully investigate if the healthcare facility is identified at which point we will file a follow-up mdr detailing the investigation.

Event Description

The user facility reported via user facility maude report the following, "steris camera handle cover was missing from the sterile packaging.The scrub tech noticed the missing item from the pack and saved the paperwork containing the lot number.".

• Brand Name: LB54 LIGHTHANDLE CAMERA COVER
• Type of Device: LIGHTHANDLE CAMERA 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 ; 4403927453
• MDR Report Key: 10652639
• MDR Text Key: 241076661
• Report Number: 1043572-2020-00046
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 10/08/2020
• 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