DIEGO 70339001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925011410), received between Dec 15, 2020 and Nov 24, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2021Corroded; Overheating of Device; Corroded; Overheating of Device

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING A DCA1401 HANDPIECE, THE HAND PIECE OVERHEATED AND THE PATIENT EXPERIENCED A BURN. NO FURTHER DETAILS ARE KNOWN. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN MADE. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 12872273 ↗
• MalfunctionMay 3, 2021Mechanical Jam; Mechanical Jam

  THE USER FACILITY REPORTED TO OLYMPUS THAT THE BLADE DID NOT MOVE ON THE DIEGO TRIGGER ENABLED HANDPIECE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759679 ↗
• MalfunctionApr 28, 2021Output Problem; Output Problem

  A REPORT OF HANDPIECE NOT FUNCTIONING AS INTENDED, WILL NOT ROTATE DURING AN UNKNOWN EVENT WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11738057 ↗
• MalfunctionMar 15, 2021Defective Device

  IT WAS REPORTED THAT THE HANDPIECE DEVICE IS NOT FUNCTIONING AS INTENDED, NOT RESPONDING AND NOT WORKING. THE MOTOR WAS DEFECTIVE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE. SERIAL NUMBER USED WAS NOT PROVIDED. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486199 ↗
• MalfunctionDec 15, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE WAS FOUND NOT FUNCTIONING AS INTENDED. THE DEVICE WHEN PLUGGED IN TO POWER ON, IT DID NOT FUNCTION AT ALL. THERE WERE NO FURTHER DETAILS PROVIDED REGARDING THE REPORTED EVENT. NO KNOWN PATIENT HARM REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11010693 ↗