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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. LIGHT SOURCE, 500XL, XENON ILLUMINATOR, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Catalog Number 72200568
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the 500xl light source stopped working and procedure postponed. No patient injury or complications were reported.
 
Manufacturer Narrative
Complaint of power up failure was confirmed. Cause of power failure is a defective power supply/balls. A corrective action was implemented for this issue.
 
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Brand NameLIGHT 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
james gonzales
7000 w. william cannon drive
austin, TX 78735
5123585706
MDR Report Key6013961
MDR Text Key57402662
Report Number1643264-2016-00187
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/06/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2015
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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