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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 Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/16/2016
Event Type  malfunction  
Event Description
It was reported that the 500xl xenon light source shut down during a procedure causing a brief loss of image during a laparoscopic appendectomy procedure. No delay was reported, and the procedure was completed using a backup device. No patient injury or complications were reported.
 
Manufacturer Narrative
Date new information received by manufacturer. Complaint of shutting down was confirmed. Product failed when power cord was inserted into pem and ballast fan ran until power button was depressed. Then ballast fan stopped and unit shut down with an e13 error which indicates overheating from a non-functional ballast fan. Cause of fan malfunction is a defective mcu pcb. Unit passes functional testing and fan performs as expected with a known good mcu pcb installed. The complaint investigation has concluded the cause of the reported failure to be a defective electronic component on the mcu pcb. A review of the manufacturing records shows that this unit was released to distribution on or about (b)(6) 2015 and has not been previously returned for service. 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 dr.
austin, TX 78735
5123585706
MDR Report Key6147645
MDR Text Key61867219
Report Number1643264-2016-00267
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 user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2016
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 Manufacturer11/25/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2015
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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