MAUDE Adverse Event Report: STERIS CORPORATION STERILE CAMERA HANDLE COVER; LIGHT, SURGICAL, ACCESSORIES

Catalog Number LB54

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2020

Event Type  malfunction  

Event Description

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.Fda safety report id# (b)(4).

• Brand Name: STERILE CAMERA HANDLE COVER
• Type of Device: LIGHT, SURGICAL, ACCESSORIES
• Manufacturer (Section D): STERIS CORPORATION; montgomery AL 36109
• MDR Report Key: 10586306
• MDR Text Key: 208783189
• Report Number: MW5096874
• Device Sequence Number: 1
• Product Code: FTA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Catalogue Number: LB54
• Device Lot Number: 6273507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1