NA 72200568SRecalls & reported problems
Smith & Nephew, Inc. · LIGHT SOURCE 500XL XENON SERVICE REPLACEMENT · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Smith & Nephew xenon light source powers fiberoptic instruments during endoscopy. The 32 reports mostly describe the unit overheating, often at setup because its cooling fans stopped working, and not powering up or shutting down unexpectedly. No deaths and no injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010650504), received between May 30, 2018 and Dec 22, 2023 — classified as 32 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (13 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up13
- Overheating of Device13
- Protective Measures Problem5
- Power Problem3
- Unexpected Shutdown2
- Device Operates Differently Than Expected1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Patient Involvement10
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING SET UP, THE 500XL XENON LIGHT SOURCE WAS OVERHEATING. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18383711 ↗MalfunctionJan 21, 2022Overheating of Device; Overheating of Device
IT WAS REPORTED THAT, DURING SET UP, THE FANS OF THE 'LIGHT SOURCE, XENON' WERE NOT ENGAGING SO THE UNIT OVERHEATED. THERE WAS A BACKUP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13320070 ↗MalfunctionJan 5, 2022Overheating of Device; Overheating of Device
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13169331 ↗MalfunctionDec 28, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE LIGHT SOURCE WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13101237 ↗MalfunctionDec 3, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY, THE 500XL XENON LIGHT SOURCE WAS OVERHEATING AND IT HAD A DOOR ERROR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 5 MINUTE DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12924021 ↗MalfunctionJun 28, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE LIGHT SOURCE WAS NOT WORKING. IT HAD SUSTAINED PHYSICAL DAMAGE AND THE FANS STOPPED WORKING SO IT OVERHEATS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12076968 ↗MalfunctionMay 26, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE WAS NOT TURNING ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11882856 ↗MalfunctionApr 28, 2021Overheating of Device; Protective Measures Problem; Overheating of Device; Protective Measures Problem
IT WAS REPORTED THAT THE LIGHT SOURCE HAD AN E12 ERROR. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11736963 ↗MalfunctionApr 15, 2021Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT, DURING SETUP FOR A SHOULDER PROCEDURE, THE LIGHT SOURCE POWERED OFF UNEXPECTEDLY. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE AND THERE WAS NO DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11676182 ↗MalfunctionMar 30, 2021Overheating of Device; Protective Measures Problem; Overheating of Device; Protective Measures Problem
IT WAS REPORTED THAT THE LIGHT SOURCE HAD A TEMPERATURE ERROR. THE INCIDENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO DELAY AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11592263 ↗MalfunctionMar 24, 2021Overheating of Device; Protective Measures Problem; Overheating of Device; Protective Measures Problem
IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN UNKNOWN SURGERY THE LIGHT SOURCE 500XL XENON WAS SHOWING A E12 ERROR WHEN TURNED ON, IT WAS UNABLE TO GET ANY LIGHT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11560993 ↗MalfunctionFeb 22, 2021Overheating of Device; Protective Measures Problem; Overheating of Device; Protective Measures Problem
IT WAS REPORTED THAT THE LIGHT SOURCE HAD A TEMPERATURE ERROR 12. INCIDENT OCCURRED AFTER THE PROCEDURE, THEREFORE, THERE WAS NOT PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11362484 ↗MalfunctionJan 30, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT DURING SET UP, THE LIGHT SOURCE, 500XL, XENON WAS NOT TURNING ON. NO PATIENT INVOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11256318 ↗MalfunctionJan 18, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE LIGHT SOURCE HAD AN E13 ERROR. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS A PATIENT INVOLVEMENT. A CANCELLATION WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11184100 ↗MalfunctionJan 14, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE LIGHT SOURCE HAD AN E12 ERROR. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11170002 ↗MalfunctionJan 14, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE DID NOT TURN ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11169798 ↗MalfunctionJan 6, 2021Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT, THE "LIGHT SOURCE (500XL, XE)"WOULD NOT TURN ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11125994 ↗MalfunctionDec 29, 2020Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LIGHT SOURCE 500 XL XENON HAD AN E13-E14 FAILURE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11090922 ↗MalfunctionDec 2, 2020Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE DID NOT TURN ON. IT IS UNKNOWN WHETHER THERE WAS A BACK UP AVAILABLE OR DELAY IN THE CASE AND IF THE EVENT HAPPENED DURING SURGERY. NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10932531 ↗MalfunctionNov 19, 2020Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE COULD NOT POWER ON, PROBABLY BECAUSE OF A BAD POWER SUPPLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 10873091 ↗MalfunctionNov 12, 2020Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE COULD NOT TURN ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 10828054 ↗MalfunctionNov 8, 2020Protective Measures Problem; Unexpected Shutdown; Protective Measures Problem; Unexpected Shutdown
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE LIGHT SOURCE SUDDENLY SHUT OFF AND PRESENTED E1, E3 AND E13 ERROR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE WITH NO SURGICAL DELAY, THE ERROR DISAPPEARED WHEN REBOOTING THE DEVICE. NO PATIENT INJURIES AND COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10806974 ↗MalfunctionSep 21, 2020Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE LIGHT SOURCE HAD A POWER FAILURE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 10564388 ↗MalfunctionSep 2, 2020Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE POWER SUPPLY OF THE XENON LIGHT SOURCE DID NOT WORK PROPERLY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 10483229 ↗MalfunctionSep 2, 2020Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE POWER SUPPLY OF THE LIGHT SOURCE WAS NOT WORKING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 10483186 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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