Surgical Straight Handpiece SGS-E2SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04560264556294), received between Nov 21, 2019 and Jul 29, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Overheating of Device” (8 reports).

8 other recalls cover devices cleared under the same FDA submission (K171155); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2025Overheating of Device; Overheating of Device

  ON JULY 16, 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 JULY 7, 2025. THE DENTIST WAS PERFORMING A THIRD MOLAR EXTRACTION PROCEDURE ON A PATIENT USING THE SGS-E2S HANDPIECE (SERIAL NO. (B)(6) DURING THE PROCEDURE, THE HANDPIECE OVERHEATED ABNORMALLY, AND THE PATIENT RECEIVED A THERMAL BURN TO THEIR EXTERNAL CHEEK. THE BURN OCCURRED WHEN THE DENTIST RESTED THE HANDPIECE ON THE PATIENT'S CHEEK DURING THE PROCEDURE, NOT REALIZING THAT IT HAD BECOME VERY HOT WHILE IN USE. THE PATIENT WAS REFERRED TO A DERMATOLOGIST FOR FURTHER TREATMENT OF THE INJURY AND IS EXPECTED TO HEAL NORMALLY WITH LITTLE TO NO SCARRING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22656976 ↗
• InjuryJul 25, 2025Overheating of Device; Overheating of Device

  THE HANDPIECE OVERHEATED ABNORMALLY DURING A THIRD MOLAR EXTRACTION PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN TO THEIR EXTERNAL CHEEK. THE BURN OCCURRED WHEN THE DOCTOR RESTED THE HANDPIECE ON THE PATIENT'S CHEEK DURING THE PROCEDURE, NOT REALIZING THAT IT HAD BECOME VERY HOT WHILE IN USE. THE PATIENT WAS REFERRED TO A DERMATOLOGIST FOR FURTHER TREATMENT OF THE INJURY AND IS EXPECTED TO HEAL NORMALLY WITH LITTLE TO NO SCARRING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 22613621 ↗
• InjuryMay 6, 2025Overheating of Device; Overheating of Device

  THE HANDPIECE OVERHEATED DURING A WISDOM TOOTH EXTRACTION PROCEDURE AND THE PATIENT RECEIVED THERMAL BURN INJURIES ON BOTH LOWER CORNERS OF THEIR MOUTH. THERE WAS NO MEDICAL TREATMENT REQUIRED AT THE TIME OF THE INJURY AND THE PATIENT IS BELIEVED TO HAVE HEALED NORMALLY WITHOUT FURTHER MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21972996 ↗
• InjuryMar 4, 2025Overheating of Device; Overheating of Device

  THE HANDPIECE OVERHEATED DURING A PROCEDURE AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. THE INJURY WAS TREATED BY THE DOCTOR IN THE OFFICE AT THE TIME OF THE INCIDENT. THE PATIENT HAS HAD A FOLLOW-UP VISIT WITH THE DOCTOR SINCE THE INCIDENT AND THE INJURY HAS HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT. (B)(6) HAS BEEN UNABLE TO OBTAIN THE DATE OF THE INCIDENT OR THE PATIENTS INFORMATION FROM THE DENTAL PRACTICE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 21518973 ↗
• InjuryMar 28, 2024Overheating of Device; Overheating of Device

  THE DOCTOR WAS CUTTING A WISDOM TOOTH WHEN THE ATTACHMENT LOCKED UP AND THE PATIENT RECEIVED A BURN INJURY TO THEIR TONGUE. NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF THE INCIDENT. THE PATIENT HAS NOT HAD A FOLLOW-UP VISIT WITH THE DOCTOR AT THIS TIME AND THE DOCTOR HAS NOT RECEIVED ANY REPORT OF COMPLICATIONS OR THE NEED FOR FURTHER MEDICAL TREATMENT FROM THE PATIENT AS A RESULT OF THE INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18999008 ↗
• InjuryOct 2, 2020Overheating of Device; Overheating of Device

  PATIENT WAS REPORTED TO HAVE RECEIVED A SLIGHT BURN TO THEIR INNER CHEEK DURING A PROCEDURE. ATTEMPTS TO OBTAIN FURTHER INFORMATION OR DETAIL ON THE EVENT HAVE BEEN UNSUCCESSFUL AT THIS TIME AND A FOLLOW UP REPORT WILL BE MADE AS MORE INFORMATION BECOMES AVAILABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10624064 ↗
• InjuryNov 21, 2019Overheating of Device; Overheating of Device

  ON (B)(6) 2019 THE DOCTOR WAS PERFORMING A WISDOM TOOTH EXTRACTION WITH THE PATIENT UNDER MODERATE SEDATION WHEN THE HANDPIECE HE WAS USING HEATED UP AND CAUSED A BURN TO THE PATIENT'S LIP. THE DOCTOR TREATED THE INJURY SITE WITH VASELINE AND NO FURTHER MEDICAL TREATMENT WAS REPORTED TO BE REQUIRED.

  Patient problems: Burn, Thermal

  MAUDE report 9358999 ↗
• InjuryNov 21, 2019Overheating of Device; Overheating of Device

  ON (B)(6) 2019 THE DOCTOR WAS PERFORMING A WISDOM TOOTH EXTRACTION ON #17 WITH THE PATIENT UNDER LOCAL ANESTHESIA WHEN THE HANDPIECE HE WAS USING HEATED UP AND CAUSED A BURN TO THE PATIENT'S LIP. THE DOCTOR PRESCRIBED MEDROL DOSEPAK FOR TREATMENT OF THE INJURY. THE DOCTOR HAS HAD A FOLLOW UP WITH THE PATIENT AND THE INJURY IS HEALING NORMALLY. NO FURTHER MEDICAL TREATMENT WAS REPORTED TO BE REQUIRED FOR TREATMENT.

  Patient problems: Burn, Thermal

  MAUDE report 9358998 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171155. One submission often covers many models, so check the product and lot details in each record.

• Z-0221-2019 · Jun 1, 2018 · Terminated
  Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: dril
• Z-0222-2019 · Jun 1, 2018 · Terminated
  Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: dr
• Z-0225-2019 · Jun 1, 2018 · Terminated
  Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includ
• Z-0220-2019 · Jun 1, 2018 · Terminated
  Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: dril
• Z-0224-2019 · Jun 1, 2018 · Terminated
  Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage include
• Z-0223-2019 · Jun 1, 2018 · Terminated
  Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage include
• Z-0219-2019 · Jun 1, 2018 · Terminated
  Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drill
• Z-0226-2019 · Jun 1, 2018 · Terminated
  Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage include