Z95LRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04560264575448), received between May 15, 2025 and May 7, 2026 — classified as 27 injuries.

The most frequently reported specific device problem is “Overheating of Device” (26 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 27 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Overheating of Device

  NSK AMERICA RECEIVED A REPORT THAT A MODEL Z95L HANDPIECE OVERHEATED ABNORMALLY DURING A DENTAL PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. THE DATE THE ADVERSE EVENT OCCURRED, PATIENT INFORMATION, AND PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT AND NSK AMERICA IS IN THE PROCESS OF COLLECTING THIS INFORMATION. A FOLLOW-UP REPORT WILL BE MADE IF THIS INFORMATION IS AVAILABLE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25117320 ↗
• InjuryMay 1, 2026Overheating of Device

  THE HANDPIECE HEAD OVERHEATED ABNORMALLY DURING A PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THE INSIDE OF THEIR LIP AND CHEEK. THE PATIENT HAS HAD MULTIPLE FOLLOW-UP APPOINTMENTS WITH THE DOCTOR AND HAS COMPLAINED OF SWELLING AT THE BURN SITE CAUSING THEM TO FREQUENTLY BITE THEIR CHEEK. THE INJURY IS HEALING NORMALLY BUT THE PATIENT HAS REPORTED NUMBNESS AT THE INJURY SITE. PATIENT INFORMATION HAS NOT BEEN PROVIDED AT THE TIME OF THIS REPORT AND A FOLLOW-UP REPORT WILL BE MADE IF THIS INFORMATION BECOMES AVAILABLE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25059791 ↗
• InjuryMay 1, 2026Material Twisted/Bent

  NSK AMERICA WAS MADE AWARE OF AN ADVERSE EVENT THAT OCCURRED IN MAY OF LAST YEAR (2025) WHILE INVESTIGATING ANOTHER ADVERSE EVENT INVOLVING THE SAME HANDPIECE. (REF. 1422375-2026-00014). THE DOCTOR REPORTED THAT THE BUR THAT THEY WERE USING BENT SUDDENLY AND STRUCK THE PATIENT'S TOOTH CAUSING IT TO FRACTURE. THE PATIENT HAS RECEIVED RESTORATIVE TREATMENT FOR THE DAMAGED TOOTH WITHOUT NEEDING ADDITIONAL TREATMENT BECAUSE OF THE INCIDENT. THIS INCIDENT WAS NEVER REPORTED TO NSK AMERICA AND THE DOCTOR CONTINUED TO USE THE DEVICE AFTER THE EVENT. NO PATIENT INFORMATION HAS BEEN PROVIDED AT THE TIME OF THIS REPORT, AND A FOLLOW-UP REPORT WILL BE MADE IF THIS INFORMATION BECOMES AVAILABLE

  Patient problems: Tooth Fracture

  MAUDE report 25059790 ↗
• InjuryApr 30, 2026Overheating of Device

  ON APRIL 10, 2026, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON MARCH 10, 2026. THE DENTIST WAS PERFORMING A FILLING PROCEDURE ON TEETH NUMBERS 3, 4, 5, 28, 30 OF A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE HANDPIECE HEAD OVERHEATED ABNORMALLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK MUCOSA. NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF THE INJURY. THE PATIENT HAS HAD A FOLLOW UP VISIT AFTER THE INCIDENT AND IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25038940 ↗
• InjuryApr 30, 2026Overheating of Device

  ON APRIL 10, 2026, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON MARCH 3, 2026. THE DENTIST WAS PERFORMING A FILLING PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6) DURING THE PROCEDURE, THE HANDPIECE HEAD OVERHEATED ABNORMALLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK MUCOSA. NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF THE INJURY. THE PATIENT HAS HAD A FOLLOW UP VISIT AFTER THE INCIDENT AND IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25038720 ↗
• InjuryApr 21, 2026Overheating of Device

  THE HANDPIECE HEAD OVERHEATED ABNORMALLY DURING A FILLING PROCEDURE ON TEETH NUMBERS 3, 4, 5, 28, 30, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK MUCOSA. NO MEDICAL TREATMENT WAS REQUIRED THE TIME OF THE INJURY. THE PATIENT HAS HAD A FOLLOW UP VISIT AFTER THE INCIDENT AND IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE END-USER DECLINED TO PROVIDE PATIENT INFORMATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24943666 ↗
• InjuryApr 21, 2026Overheating of Device

  THE HANDPIECE HEAD OVERHEATED ABNORMALLY DURING A FILLING PROCEDURE ON THE PATIENT'S LOWER TEETH AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK MUCOSA. NO MEDICAL TREATMENT WAS REQUIRED THE TIME OF THE INJURY. THE PATIENT HAS HAD A FOLLOW UP VISIT AFTER THE INCIDENT AND IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE END-USER DECLINED TO PROVIDE PATIENT INFORMATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24943665 ↗
• InjuryApr 21, 2026Overheating of Device

  THE HANDPIECE HEAD OVERHEATED ABNORMALLY DURING A FILLING PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK MUCOSA. NO MEDICAL TREATMENT WAS REQUIRED THE TIME OF THE INJURY. THE PATIENT HAS HAD A FOLLOW UP VISIT AFTER THE INCIDENT AND IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE END-USER DECLINED TO PROVIDE PATIENT INFORMATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24943663 ↗
• InjuryApr 8, 2026Overheating of Device

  DURNING A CROWN PREPARATION PROCEDURE THE DENTAL HANDPIECE BEING USED OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LOWER LEFT LIP. THE DOCTOR PRESCRIBED THE USE OF VITAMIN E OIL TO TREAT THE AFFECTED BURN AREA AT THE TIME OF THE INCIDENT. THE PATIENT IS EXPECTED TO HAVE HEALED NORMALLY FROM THE INJURY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24819327 ↗
• InjuryMar 19, 2026Overheating of Device

  ON FEBRUARY 26, 2026, NAKANISHI BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON DECEMBER 17, 2025. THE DENTIST WAS PERFORMING A RESTORATIVE FILLING PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24636038 ↗
• InjuryMar 19, 2026Overheating of Device

  ON FEBRUARY 26, 2026, NAKANISHI BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON JANUARY 29, 2026. THE DENTIST WAS PERFORMING A CROWN PREPARATION PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24636011 ↗
• InjuryMar 19, 2026Overheating of Device

  ON FEBRUARY 26, 2026, NAKANISHI BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR ((B)(4)). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON DECEMBER 12, 2025. THE DENTIST WAS PERFORMING A RESTORATIVE FILLING PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24636005 ↗
• InjuryFeb 27, 2026Overheating of Device

  DURNING A RESTORATIVE FILLING PROCEDURE THE HANDPIECE OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE DENTAL OFFICE HAS DECLINED TO PROVIDE PATIENT INFORMATION FOR THIS EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24471945 ↗
• InjuryFeb 27, 2026Overheating of Device

  DURING A RESTORATIVE FILLING PROCEDURE THE HANDPIECE OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE DENTAL OFFICE HAS DECLINED TO PROVIDE PATIENT INFORMATION FOR THIS EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24471778 ↗
• InjuryFeb 27, 2026Overheating of Device

  DURING A CROWN PREPARATION PROCEDURE THE HANDPIECE OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE DENTAL OFFICE HAS DECLINED TO PROVIDE PATIENT INFORMATION FOR THIS EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24471777 ↗
• InjuryFeb 27, 2026Overheating of Device

  DURING A CROWN PREPARATION PROCEDURE THE HANDPIECE OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE DENTAL OFFICE HAS DECLINED TO PROVIDE PATIENT INFORMATION FOR THIS EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24471776 ↗
• InjuryFeb 27, 2026Overheating of Device

  DURING A RESTORATIVE FILLING PROCEDURE THE HANDPIECE OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR INNER CHEEK. IT WAS REPORTED BY THE DENTAL OFFICE THAT THE PATIENT'S INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. THE DENTAL OFFICE HAS DECLINED TO PROVIDE PATIENT INFORMATION FOR THIS EVENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24471775 ↗
• InjuryFeb 2, 2026Overheating of Device

  ON JANUARY 9, 2026, NAKANISHI BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON DECEMBER 22, 2025. THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6). DURING THE PROCEDURE, THE HEAD OF THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THE INSIDE OF THEIR CHEEK. THE DENTIST DID NOT OBSERVE ANY INJURY TO THE PATIENT'S INNER CHEEK AT THE TIME OF THEIR TREATMENT. THE INJURY WAS REPORTED BY THE PATIENT TO THE DENTIST VIA PHONE CALL. THE PATIENT DESCRIBED HAVING A ROUND DIME SHAPED LESION THAT WAS WHITE IN COLOR ON THE INSIDE OF THEIR CHEEK WHERE THE DENTAL PROCEDURE WAS PERFORMED. FROM THE PATIENT'S DESCRIPTION, THE DENTIST BELIEVES THE BURN WAS CAUSED BY THE HANDPIECE PUSH BUTTON BACK CAP OVERHEATING DURING THE PROCEDURE DUE TO THE SHAPE AND SIZE OF THE BURN DESCRIPTION. THE DENTIST DID HAVE A FOLLOW-UP VISIT WITH THE PATIENT ON (B)(6)2026 AND FOUND THAT THE REPORTED INJURY HAD FULLY HEALED WITHOUT NEED FOR FURTHER MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24242444 ↗
• InjuryJan 21, 2026Overheating of Device

  NSK AMERICA RECEIVED A REPORT OF A PATIENT THERMAL BURN INJURY TO THE INSIDE OF THEIR CHEEK FROM A NSK MODEL Z95L HANDPIECE. THE DOCTOR DID NOT OBSERVE ANY INJURY TO THE PATIENT'S INNER CHEEK AT THE TIME OF THEIR TREATMENT. THE INJURY WAS REPORTED BY THE PATIENT TO THE DOCTOR VIA PHONE CALL. THE PATIENT DESCRIBED HAVING A ROUND DIME SHAPED LESION THAT WAS WHITE IN COLOR ON THE INSIDE OF THEIR CHEEK WHERE THE DENTAL PROCEDURE WAS PERFORMED. FROM THE PATIENT'S DESCRIPTION THE DOCTOR BELIEVES THE BURN WAS CAUSED BY THE HANDPIECE PUSH BUTTON BACK CAP OVERHEATING DURING THE PROCEDURE DUE TO THE SHAPE AND SIZE OF THE BURN DESCRIPTION. THE DOCTOR DID HAVE A FOLLOW-UP VISIT WITH THE PATIENT ON (B)(6) 2026 AND FOUND THAT THE REPORTED INJURY HAD FULLY HEALED WITHOUT NEED FOR FURTHER MEDICAL TREATMENT. THE DOCTOR DECLINED TO PROVIDE PATIENT INFORMATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24138034 ↗
• InjuryNov 13, 2025Overheating of Device; Overheating of Device

  ON OCTOBER 23, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A MINOR THERMAL BURN INJURY TO THEIR LIP.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23539567 ↗
• InjuryNov 12, 2025Overheating of Device; Overheating of Device

  THE DENTAL PRACTICE REPORTED THEIR NSK HANDPIECE OVERHEATED ABNORMALLY DURING A PROCEDURE RESULTING IN A MINOR THERMAL BURN INJURY TO THE PATIENT'S LIP. NSK AMERICA HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE DATE OF THE INCIDENT AND THE PATIENT'S INFORMATION FROM THE PRACTICE, BUT THEY HAVE BEEN UNRESPONSIVE TO OUR REQUESTS. A FOLLOW-UP REPORT WILL BE MADE IF FURTHER INFORMATION BECOMES AVAILABLE FROM THE DENTAL PRACTICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23537878 ↗
• InjuryOct 29, 2025Overheating of Device; Overheating of Device

  ON OCTOBER 8, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON OCTOBER 6, 2025. - THE DENTIST WAS PERFORMING A CROWN PREPARATION PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED ABNORMALLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LOWER LIP ON THE RIGHT SIDE. - THE PATIENT HAS HAD A FOLLOW UP WITH THE DENTIST SINCE THE INCIDENT AND IS BELIEVED TO HAVE HEALED NORMALLY WITHOUT ANY REPORTED NEED FOR ADDITIONAL MEDICAL TREATMENT FOR THE INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23420379 ↗
• InjuryOct 28, 2025Overheating of Device; Overheating of Device

  THE NSK MODEL Z95L HANDPIECE OVERHEATED ABNORMALLY DURING A CROWN PREPARATION PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LOWER LIP ON THE RIGHT SIDE. THE PATIENT HAS HAD A FOLLOW UP WITH THE DOCTOR SINCE THE INCIDENT AND IS BELIEVED TO HAVE HEALED NORMALLY WITHOUT ANY REPORTED NEED FOR ADDITIONAL MEDICAL TREATMENT FOR THE INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 23407989 ↗
• InjuryJul 10, 2025Overheating of Device; Overheating of Device

  ON JUNE 17, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON (B)(6) 2025. - THE DENTIST WAS PERFORMING A RESTORATIVE FILLING PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)) - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THE INSIDE OF THEIR CHEEK AND LIP. - THE PATIENT WAS GIVEN VITAMIN K OINTMENT TO APPLY TO THE AFFECTED AREA. - THE DENTIST HAD A FOLLOW-UP VISIT WITH THE PATIENT AND THE PATIENT IS REPORTED TO BE HEALING AS EXPECTED WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22465739 ↗
• InjuryJun 20, 2025Overheating of Device; Overheating of Device

  ON MAY 26, 2025, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON MAY 23, 2025. - THE DENTIST WAS PREPARING TOOTH #18 FOR A MESIO-OCCLUSO-DISTAL COMPOSITE RESIN RESTORATION ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LEFT BUCCAL MUCOSA APPROXIMATELY 1CM IN SIZE. - NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF THE INJURY AND THE AFFECTED AREA IS EXPECTED TO HEAL NORMALLY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22294691 ↗