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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SVCE REPL, LIGHT SOURCE, 500XL, XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Catalog Number 72200568S
Device Problem Overheating of Device (1437)
Patient Problem No Information (3190)
Event Date 07/25/2014
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the light source was overheating.
 
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Brand NameSVCE REPL, LIGHT SOURCE, 500XL, XENON
Type of DeviceIMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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
james gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6966371
MDR Text Key90656383
Report Number1643264-2017-00795
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 10/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200568S
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/25/2014
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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