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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 Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2020
Event Type  malfunction  
Event Description
It was reported that when the light source was power on, the fan on the right side of the host worked (behind the circuit board), however, the fan did not rotated when turned on.The host shut down automatically after working for half an hour, after 10 minutes it turn on again.No patient injuries or delay reported.Smith and nephew device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.The customer provided image confirms the device is a 500xl xenon light source, but provides no serial number or functional information.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.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
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Brand Name
LIGHT SOURCE 500XL XENON
Type of Device
IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10494648
MDR Text Key205689373
Report Number1643264-2020-01048
Device Sequence Number1
Product Code FFS
UDI-Device Identifier03596010643070
UDI-Public03596010643070
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
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72200568
Device Catalogue Number72200568
Device Lot NumberBBR9477
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/10/2020
Initial Date FDA Received09/04/2020
Supplement Dates Manufacturer Received09/29/2020
Supplement Dates FDA Received09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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