NA 72200568Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 03596010643070), received between Sep 20, 2017 and Dec 19, 2024 — classified as 3 injuries, 104 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (35 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE LIGHT SOURCE BRIGHTNESS SUDDENLY DIMMED. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20984718 ↗
• MalfunctionDec 8, 2024Overheating of Device; Arcing; Unexpected Shutdown; Overheating of Device; Arcing; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING LEFT ANKLE ARTHROSCOPY, THE LIGHT SOURCE 500 XL XENON WAS OVERHEATED, IT SPARKED AND SHOUT DOWN, LATER THE CONSOLED WAS TURNED ON AND THE INTERNAL FANS WERE NOT ACTIVATING. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, AND IT WAS NECESSARY TO CHANGE THE SURGICAL TECHNIQUE DUE TO THE FAILURE. THERE WAS A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875257 ↗
• MalfunctionOct 31, 2024Insufficient Device Problem Information; Unexpected Shutdown; Insufficient Device Problem Information; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE XENON LIGHT SOURCE TURNED OFF, LEAVING ONLY THE LIGHT OFF. THE DEVICE REMAINED ON AND DISPLAYED AN ERROR OR DEFECT ON THE DEVICE'S SCREEN. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS OF 60 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577267 ↗
• MalfunctionSep 5, 2024Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE XENON LIGHT SOURCE SUDDENLY LOST POWER THREE (3) TIMES, WHICH SERIOUSLY AFFECTED THE OPERATIVE FIELD AND THE TARGET ISSUE COULD NOT BE SEEN. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20153392 ↗
• MalfunctionMar 18, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE LIGHT SOURCE WOULD NOT TURN ON. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18922294 ↗
• InjuryOct 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE LIGHT SOURCE WAS OPERATING ERRATICALLY AND IT WAS DEACTIVATED. THE PROCEDURE WAS STOPPED DUE TO THE REPORTED MALFUNCTION. IT IS UNKNOWN IF THE CASE WAS COMPLETED NOR HOW, OR IF THE PATIENT WAS RESCHEDULED FOR ANOTHER SURGERY. IT IS UNKNOWN OF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17862184 ↗
• InjuryAug 17, 2023Electrical /Electronic Property Problem; Unexpected Shutdown; Electrical /Electronic Property Problem; Unexpected Shutdown

  IT WAS REPORTED THAT, DURING A LEFT KNEE MENISCUS REVISION SURGERY, WHILE USING THE ARTHROSCOPE TO EXPOSE THE SURGICAL FIELD OF VIEW, THE LIGHT SOURCE SUDDENLY MALFUNCTIONED AND CUT OUT, PREVENTING NORMAL OPERATION. AT THE TIME OF THE INCIDENT, THE DEVICE WAS TRIMMING A PORTION OF THE MENISCUS THAT WAS HYPERPLASTIC AND THE SUDDEN EXTINGUISHING OF THE LIGHT SOURCE CAUSED THE PLANER BLADE TO SCRATCH THE PATIENT'S ARTICULAR BONY LAYER DURING THE SHUTDOWN AND EXTRACTION, WHICH CAUSED INJURY TO THE PATIENT, RESULTING IN PROLONGED SURGERY TIME AND INCREASED RISK OF INFECTION. AT THE SAME TIME, A BURNING ODOR COULD BE SMELLED COMING FROM THE DEVICE, AND THE LIGHT SOURCE KEPT DISPLAYING THE E12 FAULT CODE. IMMEDIATELY A POWER-OFF OPERATION WAS PERFORMED. THE EVENT DID NOT RESULT IN SPARKING, ARCING, SMOKING, AND/OR OVERHEATING OF THE DEVICE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A STRYKER ARTHROSCOPE. DUE TO THE LOCATION OF THE DAMAGED BONE WITHIN THE PATIENT'S JOINT, ONLY ENHANCED OBSERVATION WAS POSSIBLE TO ASSESS IF THERE WAS ANY IMPACT ON THE PATIENT'S RECOVERY. THE PATIENT HAD NO ABNORMALITIES AND RECOVERED WELL.

  Patient problems: Laceration(s)

  MAUDE report 17568215 ↗
• MalfunctionJul 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A JOINT SURGERY, WHEN THE LIGHT SOURCE WAS TURNED ON, THE DOCTOR FOUND THAT IT COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257056 ↗
• MalfunctionJun 19, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCUS REPAIR, THE LIGHT SOURCE COULD NOT BE TURNED ON AND THERE WAS NO LIGHT. A DELAY GREATER THAN 30 MINUTES WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A OLYMPUS COMPETITOR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159029 ↗
• MalfunctionSep 28, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE LIGHT SOURCE BECAME HOT ABOUT TWO MINUTES AFTER IT WAS TURNED ON. THE DEVICE WAS INTENDEDLY TURNED OFF AS A PREVENTIVE MEASURE. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING THE SAME REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499407 ↗
• MalfunctionSep 9, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE, A LIGHT SOURCE, SUDDENLY DARKENED, SHUT DOWN AND RESTARTED ITSELF. SURGERY WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES WITH THE REPORTED FACULTY DEVICE, SHUTTING IT DOWN FOR A WHILE AND RESTARTING IT, SO BACK AND FORTH. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397364 ↗
• MalfunctionAug 29, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE LIGHT SOURCE SUDDENLY WENT OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF MORE THAN 31 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316859 ↗
• MalfunctionJun 7, 2022Smoking; Smoking

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHILE THE PATIENT WAS ANESTHETIZED, AFTER SWITCHING ON THE LIGHT SOURCE CONSOLE AND PLUGGING IN THE CABLE, IT STARTED TO PRODUCE SMOKE FROM THE SIDES AND BEHIND. THE ERROR MESSAGE ON THE DISPLAY WAS: ¿LAMP FAIL. E13". THE PROCEDURE WAS COMPLETED USING A COMPETITOR DEVICE. AN UNSPECIFIED DELAY WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622392 ↗
• MalfunctionMay 12, 2022Electrical /Electronic Property Problem; Overheating of Device; Electrical /Electronic Property Problem; Overheating of Device

  IT WAS REPORTED THAT DURING SET UP, THE 'LIGHT SOURCE' DISPLAYED AN ERROR E12 "TEMPERATURE ERROR" WHEN IT WAS TURNED ON, THE DEVICE OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14381038 ↗
• MalfunctionFeb 9, 2022Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE IMAGE OF A LIGHT SOURCE FLASHED. SURGERY WAS RESUMED WITH A DELAY GREATER THAN 30 MINUTES, USING A THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13496761 ↗
• MalfunctionNov 24, 2021Overheating of Device; Protective Measures Problem; Unexpected Shutdown; Overheating of Device; Protective Measures Problem; Unexpected Shutdown

  IT WAS REPORTED THAT A PATIENT WAS HOSPITALIZED DUE TO LATERAL COLLATERAL LIGAMENT INJURY. DURING THE EXAMINATION OF THE INJURY, THE LIGHT SOURCE 500XL XENON SUDDENLY ALERTED WITH AN E13 ERROR, AND THE LIGHT WENT OUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12871104 ↗
• MalfunctionNov 10, 2021Overheating of Device; Overheating of Device

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786134 ↗
• MalfunctionOct 28, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE LIGHT SOURCE'S THE DEVICE WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12714938 ↗
• MalfunctionOct 27, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE FANS OF THE LIGHT SOURCE WERE NOT WORKING AND THE DEVICE WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702347 ↗
• MalfunctionOct 27, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE FANS OF THE LIGHT SOURCE 500XL XENON WERE NOT WORKING AND THE DEVICE WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12702339 ↗
• MalfunctionAug 6, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE LIGHT SOURCE FANS WERE NOT WORKING AND THE DEVICE WAS OVERHEATING. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291619 ↗
• MalfunctionJul 27, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE 500XL XENON LIGHT SOURCE WAS NOT GETTING ON. NO CASE INVOLVED. THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12234834 ↗
• MalfunctionJul 19, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT, DURING INSPECTION, THE LIGHT SOURCE 500XL WAS NOT POWERING ON. A BACKUP DEVICE WAS AVAILABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12193292 ↗
• MalfunctionJun 23, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING ROUTINE INSPECTION IT WAS FOUND THAT THE LIGHT SOURCE 500XL XENON WAS NOT SWITCHING ON. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048552 ↗
• MalfunctionJun 17, 2021Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE LIGHT SOURCE WAS NOT SWITCHING ON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12015815 ↗