MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY AMSCO EXAMINER 10 LIGHTING SYSTEM

Device Problem Sparking (2595)

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

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

The reported event did not occur during a procedure, no patient impact occurred as a result.The amsco examiner 10 lighting system is constructed on a mobile stand and is required to be plugged into a power source to be used.A steris service technician arrived on site, inspected the light, and identified the insulation on the power cord for the light was damaged causing the wire to be exposed and resulting in the reported spark.The technician identified this abrasion on the insulation was most likely caused by the user facility stretching the power cord too far when using the lighting system.The technician replaced the damaged insulation, installed wire ties on the power cord to prevent it from being stretched in the future, tested the lighting system, and confirmed it to be operating according to specification.The technician notified the user facility to refrain from stretching the power cord on the lighting system to prevent future recurrence.No additional issues have been reported.

Event Description

The user facility reported the power cord on their amsco examiner 10 lighting system sparked.No injury, procedure delay, or cancellation was reported.

• Brand Name: AMSCO EXAMINER 10 LIGHTING SYSTEM
• Type of Device: 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6449124
• MDR Text Key: 71621240
• Report Number: 1043572-2017-00022
• 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: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2017
• 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