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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 ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE

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SMITH & NEPHEW, INC. SVCE REPL, LIGHT SOURCE, 500XL, XENON ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Catalog Number 72200568S
Device Problem Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
It was reported the bulb casing melted around the bulb on the lightsource. This occurred before a procedure. No delays or patient injuries were reported.
 
Manufacturer Narrative
Device investigation narrative - complaint of overheating was confirmed. Unit shuts down after 10 minute warm up because cooling fan for lamp is not activated upon lamp ignition. Cause of lamp cooling fan failure is a defective mcu pcb. Unit passes functional testing and fans perform as expected with a known good mcu pcb installed. The complaint investigation has concluded that this unit has succumbed to expected wear and tear since unit is over 3 and a half years old.
 
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Brand NameSVCE REPL, LIGHT SOURCE, 500XL, XENON
Type of DeviceILLUMINATOR, 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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key6186176
MDR Text Key63104800
Report Number1643264-2016-00293
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200568S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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