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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 Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during a surgery, the light source 500xl xenon had a temperature error e06 on the screen, the device was restarted and the issue continued. The device become hot to touch. It is unknown if there was an available back up device or a significant delay during the procedure. No patient injury or other complications 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
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 Key12786134
MDR Text Key280575112
Report Number1643264-2021-02402
Device Sequence Number1
Product Code FFS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K994084
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200568
Device Catalogue Number72200568
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
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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