MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY EXAMINER 10 LIGHT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the examiner 10 light.While onsite, the technician was informed by facility personnel that they contacted steris to request functional testing of the examiner 10 light in an attempt to rule out the light as a root cause of the reported burn.The technician performed an inspection and found the light to be operating properly.No issue with the function or operation of the light was identified; no repairs were required.Steris understands that the hospital is conducting an investigation of the reported event, including the use of a topical treatment that was administered to the patient prior to the start of the procedure as a potential root cause.The hospital has not provided steris further information regarding the topical treatment applied.No additional issues have been reported.

Event Description

The user facility reported that while using their examiner 10 light a patient obtained a burn.

• Brand Name: EXAMINER 10 LIGHT
• Type of Device: LIGHT
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9771451
• MDR Text Key: 202018419
• Report Number: 1043572-2020-00014
• Device Sequence Number: 1
• Product Code: KZF
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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
• Date Manufacturer Received: 01/29/2020
• 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