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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the surgical lights, and confirmed the reported damage.The technician applied electrical tape to the damaged wires, tested the lights, and confirmed them to be operating according to specification.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 wire down and allowed for the wire to become exposed.The amsco examiner 10 surgical light complies with ul 544 and iec 60601-1 requirements.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 that their amsco examiner 10 surgical lights evidenced damage to the wires.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: 5492565
• MDR Text Key: 40327433
• Report Number: 1043572-2016-00020
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• 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: 02/10/2016
• 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