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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 Problems Loss of Power (1475); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/19/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting. The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
Event Description
It was reported that when the device was turned on before the procedure, the device had a power down suddenly with a explosive sound. The procedure was complete with a back-up device. After the problem happened, the device was inspected at our service team. It was confirmed that one of the cooling fan stopped working when the lamp illuminated.
 
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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 west william cannon drive
austin, TX 78735
MDR Report Key7181485
MDR Text Key135369204
Report Number1643264-2018-00036
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2018
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2018
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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