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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. LIGHT SOURCE, 500XL, XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Catalog Number 72200568
Device Problems Melted (1385); Overheating of Device (1437); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/24/2017
Event Type  malfunction  
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. There was a relationship found between the subject device and the reported incident. An analysis of the customer provided pictures showed the lamp heat sink melted into the lamp housing. This confirmed the complaint and the root cause has been associated with an electrical component failure.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported the light source 500xl lamp cooling fan stopped rotating causing the lamp heat sink to overheat and melt into the lamp housing casing/carrier plate. No patient injury or complications were reported.
 
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Brand NameLIGHT 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
jim gonzales
7000 w. william cannon drive
austin, TX 78735
MDR Report Key6514854
MDR Text Key138828032
Report Number1643264-2017-00220
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200568
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/08/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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