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NA 72202439Recalls & reported problems

Smith & Nephew, Inc. · REPLACEMENT LAMP MODULE, 500XL XENON · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010643063), received between Oct 7, 2019 and Jan 21, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

Most reported problems

Device problems

  • Insufficient Device Problem Information1
  • Overheating of Device1
  • Unexpected Shutdown1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 21, 2021Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE XENON LAMP MODULE BURNED OUT AFTER 480 HOURS. THERE WAS SOME BLACKENING ON THE MODULE WHICH INDICATED THAT THERE HAS BEEN SOME FORM OF OVERHEATING. 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 11206268 ↗
  • MalfunctionOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT DURING AN ACL PROCEDURE DEVICE SHUT OFF, THE PROCEDURE WAS COMPLETED USING A COMPETITORS CONMED LIGHT SOURCE. NO SIGNIFICANT DELAY OR PATIENT INJURIES REPORTED. NO BACK-UP DEVICE AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9189215 ↗
  • MalfunctionOct 7, 2019Unexpected Shutdown; Unexpected Shutdown

    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.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9164937 ↗

Other image, illumination, fiberoptic, for endoscope devices

All image, illumination, fiberoptic, for endoscope devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.