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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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SMITH & NEPHEW, INC. RFB LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Model Number 72200568F
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/21/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the device was overheating.No patient injury was reported.
 
Additional Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
 
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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 Key7305540
Report Number1643264-2018-00184
Device Sequence Number1261066
Product Code FFS
UDI-Device Identifier00885556571392
UDI-Public(01)00885556571392
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
K994084
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 04/16/2018
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 Number72200568F
Device Catalogue Number72200568F
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/21/2018
Supplement Date Received by Manufacturer04/06/2018
Initial Report FDA Received Date03/01/2018
Supplement Report FDA Received Date04/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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