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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
Model Number 72200568
Device Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/31/2017
Event Type  malfunction  
Manufacturer Narrative
Device investigation narrative - the device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Functional evaluation revealed the ballast fan shuts down when unit is powered up, and ballast overheats. The complaint of overheating was confirmed. Cause of fan malfunction 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 the cause of the failure to be a defective electronic component. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. Device evaluated by the manufacturer. Evaluation codes updated. (b)(4).
 
Event Description
It was reported that the device was overheating before a procedure. No injuries 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 dr
austin, TX 78735
MDR Report Key6878266
MDR Text Key117305757
Report Number1643264-2017-00554
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 faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200568
Device Catalogue Number72200568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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