MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Model Number	72200568F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the light source had a burnt resistor, resulting in overheating.No patient injury reported.Procedure completed with the same device.
Additional Manufacturer Narrative
There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.A burnt resistor was found on the power supply.The light source failed power up.Cause of power failure is a defective power supply/ballast.Unit powered up and passed functional testing with a known good power supply installed.The complaint was confirmed and the investigation has concluded the cause of the failure to be a defective electronic component.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: RFB LIGHT SOURCE 500XL XENON
• Common Device Name: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7044280
• Report Number: 1643264-2017-01740
• Device Sequence Number: 1259999
• Product Code: FFS
• UDI-Device Identifier: 00885556571392
• UDI-Public: (01)00885556571392
• Combination Product (Y/N): N
• PMA/510(K) Number: K994084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72200568F
• Device Catalogue Number: 72200568F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/19/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1