Surgical Angle Handpiece SGA-E2SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04560264556287), received between Nov 25, 2019 and Jul 7, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Overheating of Device” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 2026Overheating of Device

  DURING AN EXTRACTION OF THE PATIENT'S THIRD MOLAR THE SGA-E2S HANDPIECE OVERHEATED UNEXPECTEDLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. THE PATIENT'S INJURY WAS TREATED AT THE TIME OF THE INCIDENT WITHOUT NEED FOR ADDITIONAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25739980 ↗
• InjuryJul 7, 2026Overheating of Device

  THE DOCTOR HAD THEIR SGA-E2S HANDPIECE OVERHEAT UNEXPECTEDLY DURING A THIRD MOLAR EXTRACTION AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. THE PATIENT'S INJURY WAS TREATED AT THE TIME OF THE INCIDENT WITHOUT NEED FOR ADDITIONAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25739979 ↗
• InjuryJun 23, 2026Overheating of Device

  DURING AN ORAL SURGERY TOOTH EXTRACTION PROCEDURE THE SGA-E2S HANDPIECE OVERHEATED UNEXPECTEDLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. THE PATIENT'S INJURY WAS TREATED AT THE TIME OF THE INCIDENT WITHOUT ANY REPORTED NEED FOR ADDITIONAL TREATMENT. THE PATIENT HAS NOT HAD A FOLLOW UP WITH THE DOCTOR SINCE THE INCIDENT BUT IS BELIEVED TO HAVE HEALED NORMALLY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25598309 ↗
• InjuryJun 23, 2026Overheating of Device

  DURING AN EXTRACTION OF THE PATIENT'S THIRD MOLAR THE SGA-E2S HANDPIECE OVERHEATED UNEXPECTEDLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. THE PATIENT'S INJURY WAS TREATED AT THE TIME OF THE INCIDENT WITHOUT ANY REPORTED NEED FOR ADDITIONAL TREATMENT. THE PATIENT HAS NOT HAD A FOLLOW UP WITH THE DOCTOR SINCE THE INCIDENT BUT IS BELIEVED TO HAVE HEALED NORMALLY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 25598308 ↗
• InjuryApr 17, 2026Overheating of Device

  ON MARCH 25, 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 (B)(6) 2026. - THE DENTIST WAS PERFORMING AN EXTRACTION AND BONE GRAFT PROCEDURE ON #2 AND #15 TEETH OF A PATIENT USING THE SGA-E2S HANDPIECE (SERIAL NO. (B)(6)). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LOWER LEFT LIP AND CHIN APPROXIMATELY 1 INCH IN LENGTH. - DUE TO THE EXTERNAL LOCATION OF THE INJURY SITE THE PATIENT CONSULTED WITH A DERMATOLOGIST AND ALTHOUGH THE WOUND IS HEALING NORMALLY, THE PATIENT MAY BE LEFT WITH A PERMANENT VISIBLE SCAR THAT MAY REQUIRE PLASTIC SURGERY TO MINIMIZE ITS APPEARANCE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24906308 ↗
• InjuryMar 25, 2026Overheating of Device

  THE SUBJECT HANDPIECE OVERHEATED DURING AN EXTRACTION AND BONE GRAFT PROCEDURE ON #2 AND #15 TEETH AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LOWER LEFT LIP AND CHIN APPROXIMATELY 1 INCH IN LENGTH. DUE TO THE EXTERNAL LOCATION OF THE INJURY SITE THE PATIENT CONSULTED WITH A DERMATOLOGIST AND ALTHOUGH THE WOUND IS HEALING NORMALLY, THE PATIENT MAY BE LEFT WITH A PERMANENT VISIBLE SCAR THAT MAY REQUIRE PLASTIC SURGERY TO MINIMIZE ITS APPEARANCE.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24692578 ↗
• InjuryFeb 11, 2026Overheating of Device

  DURING A TOOTH EXTRACTION PROCEDURE THE HANDPIECE OVERHEATED AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP ON THE RIGHT SIDE. NO MEDICAL TREATMENT WAS REQUIRED AT THE TIME OF THE INCIDENT AND THE PATIENT IS REPORTED TO HAVE HEALED NORMALLY WITHOUT NEED FOR ADDITIONAL MEDICAL TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24317867 ↗
• InjurySep 23, 2020Overheating of Device; Overheating of Device

  PATIENT RECEIVED A SUPERFICIAL BURN TO THEIR LIP DURING APICOECTOMY PROCEDURE ON NUMBER 19 TOOTH. PATIENT WAS UNDER DEEP SEDATION AT THE TIME OF THE EVENT. ANTIBIOTIC OINTMENT WAS APPLIED TO THE BURN. THE PATIENT IS REPORTED TO BE HEALING NORMALLY WITH NO COMPLICATIONS OR NEED FOR FURTHER MEDICAL TREATMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 10577461 ↗
• InjuryMar 23, 2020Overheating of Device; Overheating of Device

  DOCTOR WAS PERFORMING AN EXTRACTION OF 3RD MOLARS WITH THE PATIENT UNDER GENERAL ANESTHESIA WHEN BLISTERING WAS OBSERVED ON THE CORNER OF PATIENTS RIGHT LOWER LIP. INJURY WAS CLEANED AND NEOSPORIN WAS ADMINISTERED TO THE AREA. DOCTOR HAS CONDUCTED A FOLLOW UP WITH THE PATIENT AND THE INJURY HAS HEALED AS EXPECTED. NO FURTHER MEDICAL TREATMENT WAS REQUIRED FOR THIS INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9868079 ↗
• InjuryMar 23, 2020Overheating of Device; Overheating of Device

  DOCTOR WAS PERFORMING AN EXTRACTION OF 3RD MOLARS WITH THE PATIENT UNDER GENERAL ANESTHESIA WHEN BLISTER THE APPROXIMATELY THE SIZE OF A PEA WAS OBSERVED ON THE CORNER OF PATIENTS RIGHT LOWER LIP. INJURY WAS CLEANED AND NEOSPORIN WAS ADMINISTERED TO THE AREA. DOCTOR HAS CONDUCTED A FOLLOW UP WITH THE PATIENT AND THE INJURY HAS HEALED NORMALLY. NO FURTHER MEDICAL TREATMENT REQUIRED FOR THIS INJURY.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9868064 ↗
• InjuryNov 25, 2019Overheating of Device; Overheating of Device

  ON (B)(6) 2019 DOCTOR (B)(6) WAS PERFORMING A REMOVAL OF HORIZONTAL IMPACTED TOOTH #17 ON THE PATIENT UNDER LOCAL ANESTHESIA WHEN THE TIP OF THE HANDPIECE OVERHEATED AND CAUSED A THERMAL BURN TO THE PATIENTS LOWER LEFT LIP. THE PATIENT WAS INSTRUCTED BY THE DOCTOR TO APPLY OINTMENT TO TREAT THE INJURY SITE. THE BURN IS REPORTED TO BE HEALING NORMALLY BUT MAY LEAVE A PERMANENT SCAR WHICH MAY REQUIRE REFERRAL TO A SPECIALIST FOR TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9369862 ↗

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-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-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-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-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
• 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-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