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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 06/22/2020
Event Type  malfunction  
Event Description
It was reported that the light source could not turn on.Incident occurred before a rotator cuff procedure.There was a delay of 31-60min and a back-up device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A complaint history review concluded this was a repeat issue.A review of manufacturing records found the device has been in service for over 5 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A relationship, if any, between the subject device and the reported event could not be determined.Factors unrelated to the manufacturing and design of the device which could have contributed to the reported event, include a defective power supply/ballast or other related electrical components.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.Internal complaint reference: (b)(4).
 
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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 Key10279913
MDR Text Key199056710
Report Number1643264-2020-00572
Device Sequence Number1
Product Code FFS
UDI-Device Identifier03596010643070
UDI-Public03596010643070
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/04/2021
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 NumberBBR5204
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/22/2020
Initial Date FDA Received07/15/2020
Supplement Dates Manufacturer Received08/02/2021
Supplement Dates FDA Received08/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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