MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 500 XL ELITE XENON; LIGHT SOURCE, 500XL, XENON

Catalog Number 72200568

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

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

Event Date 06/02/2015

Event Type  malfunction  

Event Description

During unknown procedure, the lamp fan was not working and this caused the lamp unit to rapidly overheat, melt and burn the housing.The users only recognized the problem when they smelled a burning smell coming from the stack.Sales rep.Stated that he checked the unit over and it looked like the fan driver board is at fault as you can replicate the fault on the power supply fan by swapping the fan supplies.A back-up was available to complete the procedure.There was a 15 minute delay while they swapped out the machines.

Manufacturer Narrative

Although anticipated, the device evaluation has yet to begun.When the evaluation of the device is completed, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

The reported complaint has been confirmed and the root cause was found to be a defective capacitor in the fan pcb assembly and damage from excessive lamp heat was found internally.Heat sensor u1 was found to be bent and out of proper position, which may have contributed to excessive internal heat.The lamp module that was returned with this unit has been altered by a third party, the bulb has been replaced.Smith & nephew recommends that only lamp modules with certain design characteristics be used.The ifu clearly states that the use of any other lamp module will void the warranty and may cause the light cable to overheat creating the risk of patient burns and/or fire.The reported complaint states that the defective lamp fan would cause the unit to rapidly ¿over heat, melt and burn the housing¿.It is believed that the heat damage to the lamp housing and other components happened over time as a result of the following conditions: 1.Removing the ac power at power down rather than using the power switch.2.The use of a third party lamp.3.Heat sensor u1 was found to be bent and out of proper position.

• Brand Name: 500 XL ELITE XENON
• Type of Device: LIGHT SOURCE, 500XL, XENON
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 150 minuteman road; andover, MA 01826 ; 5123585706
• MDR Report Key: 4887842
• MDR Text Key: 6534509
• Report Number: 1643264-2015-00034
• Device Sequence Number: 1
• Product Code: FFS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K994084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72200568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2012
• 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