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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

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SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE Back to Search Results
Model Number 72200568S
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Event Description
It was reported that the rfb light source 500xl xenon was overheating. The incident occurred before the procedure. There was non delay and a backup device was available to complete the procedure with no complications reported.
 
Manufacturer Narrative
Internal complaint reference (b)(4).
 
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Brand NameSVCE REPL LIGHT SOURCE 500XL XENON
Type of DeviceIMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key13169331
MDR Text Key285673384
Report Number1643264-2022-00010
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200568S
Device Catalogue Number72200568S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/04/2022
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

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