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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 72200568
Device Problems Smoking (1585); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2014
Event Type  malfunction  
Event Description
It was reported that during the procedure, the unit started to smoke and the red light inside came on.
 
Manufacturer Narrative
The device was returned for evaluation where product investigation revealed that smoke was caused by a burned resistor on the power supply/ballast.No further investigation is required.(b)(4).
 
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Brand Name
SVCE REPL, LIGHT SOURCE, 500XL, XENON
Type of Device
ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 651
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 651
Manufacturer Contact
jim gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key4935362
MDR Text Key16526801
Report Number1643264-2015-00060
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/22/2015
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
Device Operator Health Professional
Device Catalogue Number72200568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/22/2015
Initial Date FDA Received07/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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