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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 Problems Loss of Power (1475); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported the light source 500xl presented an "e-13" error message and had a power failure during the procedure. No smith & nephew back up device available. Competitive device utilized to complete the procedure. No patient injury or complications were reported.
 
Manufacturer Narrative
Complaint of e-13 error and power failure was confirmed. Cause of power failure and 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 record for serial number (b)(4) shows that this unit passed all acceptance criteria and was compliant upon release for distribution on (b)(6) 2016. No containment or corrective actions are recommended at this time.
 
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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
jim gonzales
7000 w. william cannon drive
austin, TX 
MDR Report Key6389763
MDR Text Key69752449
Report Number1643264-2017-00135
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
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 Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/25/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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