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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
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 08/10/2017
Event Type  malfunction  
Manufacturer Narrative
There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the exterior of product and no physical damage was observed. Functional evaluation confirmed the complaint of an e-13 error and power failure. 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 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. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that the unit displayed an e13 error code and powered down. As a result, visualization was lost with instrumentation inside the patient. A backup light source was used to complete the procedure. No complications or injuries 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 drive
austin, TX 78735
MDR Report Key6814289
MDR Text Key130064927
Report Number1643264-2017-00494
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72200568
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2017
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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