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

Device Problem Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

While the technician was onsite, the user facility disclosed that an event occurred on a second surgical light a few months ago.The user facility indicated the surgical light was not in use for this occurrence.This unit had been repaired prior to steris's inspection of the unit.The amsco examiner 10 surgical light complies with ul 544 and iec 60601-1 requirements regarding its power entry module and for very low leakage current rates for medical electrical equipment.Steris's inspection of the wires evidenced damage to the insulation surrounding the wires.Over time, various manipulations of the lighthead assembly wore the damaged wires down and allowed for the wires to become exposed.Steris has been unable to determine the source of the damage on the power wires' insulation because the reported damage was repaired by the user facility's biomedical technician prior to the steris technician's inspection.Section 4.2 routine inspection of the maintenance manual for the examiner 10 surgical light states, "check electrical components for loose wires, improper connections, and other obvious defects." the surgical light is not under steris contract agreement for maintenance.The hospital's biomedical technician is responsible for maintenance.

Event Description

The user facility reported their amsco examiner 10 surgical light was not in use when it sparked.No report of injury or procedural delay or cancellation.

• Brand Name: AMSCO EXAMINER 10 SURGICAL LIGHT
• Type of Device: SURGICAL LIGHT
• 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: 5477681
• MDR Text Key: 39845478
• Report Number: 1043572-2016-00018
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• 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: 02/03/2016
• 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