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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 Problem Unexpected Shutdown (4019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that, during an acl reconstruction surgery, the 500 xl light source shut off.The procedure was finished with a competitor device after a slight surgical delay.The patient was not harmed.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 relationship, if any, between the subject device and the reported event could not be determined.
 
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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 6512
MDR Report Key9164937
MDR Text Key163193291
Report Number1643264-2019-00679
Device Sequence Number1
Product Code FFS
UDI-Device Identifier03596010643063
UDI-Public03596010643063
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 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72200568
Was Device Available for Evaluation? No
Date Manufacturer Received11/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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