DIEGO ELITE MDHP100ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00821925027749), received between Jan 11, 2021 and May 12, 2021 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Output Problem” (10 reports).

12 other recalls cover devices cleared under the same FDA submission (K123429); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2021Output Problem; Output Problem

  DEVICE NOT FUNCTIONING AS INTENDED, COMES UP WITH ERROR CODE ASKING TO REINSERT THE HANDPIECE DURING PREPARATION FOR USE 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 11811652 ↗
• MalfunctionMay 5, 2021Output Problem; Output Problem

  A REPORT OF HANDPIECE NOT FUNCTIONING AS INTENDED, NOT IDENTIFYING ON CONSOLE DURING PREPARATION FOR USE 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 11779992 ↗
• MalfunctionMay 5, 2021Defective Device; Output Problem; Defective Device; Output Problem

  A REPORT OF DEVICE STOPPED WORKING, FAULT WITH HANDPIECE DURING PREPARATION FOR USE WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS RELATED TO REPORT PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778455 ↗
• MalfunctionMay 5, 2021Defective Device; Output Problem; Defective Device; Output Problem

  A REPORT OF DEVICE STOPPED WORKING, FAULT WITH HANDPIECE DURING PREPARATION FOR USE WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS RELATED TO REPORT PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11778430 ↗
• MalfunctionMay 4, 2021No Device Output; No Device Output

  AS REPORTED FOR THIS EVENT, DURING PREPARATION FOR USE A HANDPIECE ERROR CODE WAS RECEIVED. THE DEVICE WAS NOT FUNCTIONAL. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769994 ↗
• MalfunctionApr 26, 2021Intermittent Energy Output; Intermittent Energy Output

  THE SERVICE CENTER WAS INFORMED THAT DURING A THERAPEUTIC FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, PREPARATION FOR USE, THE HAND-PIECE WORKED INTERMITTENTLY WHEN ACTIVATED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THIS WAS AN ISOLATED EVENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11727542 ↗
• MalfunctionApr 23, 2021Defective Device; Output Problem; Defective Device; Output Problem

  THE DEVICE NOT FUNCTIONING AS INTENDED, WHEN PEDAL WAS STEPPED ON, NOTHING HAPPENS WITH THE HANDPIECE WAS REPORTED. THE ISSUE FOUND DURING PREPARATION FOR USE. NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713109 ↗
• MalfunctionApr 22, 2021Communication or Transmission Problem; Communication or Transmission Problem

  AS REPORTED FOR THIS EVENT, DURING PREPARATION FOR USE THE CONSOLE DID NOT IDENTIFY THE DEVICE. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11706302 ↗
• MalfunctionApr 19, 2021Output Problem; Output Problem

  COMMUNICATION ERROR WITH HAND PIECE WAS REPORTED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11689371 ↗
• MalfunctionApr 5, 2021No Device Output; No Device Output

  THE USER FACILITY REPORTED THAT THE HANDPIECE WAS NOT RECOGNIZED BY EITHER CONSOLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612795 ↗
• MalfunctionMar 8, 2021No Device Output; Defective Device; No Device Output; Defective Device

  IT WAS REPORTED THAT THE HANDPIECE IS NOT FUNCTIONING AS INTENDED. THE DEVICE SHOWED ERROR MESSAGE ¿E12 ERROR¿. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440219 ↗
• MalfunctionFeb 24, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF AN UNSPECIFIED PROCEDURE, THE HANDPIECE WAS NOT FUNCTIONING AS INTENDED. THE SYSTEM WAS NOT READING THE UNIT. IT WAS SUSPECTED THAT SOMETHING MAYBE WRONG WITH THE ELECTRICAL CIRCUIT. THE INTENDED PROCEDURE WAS COMPLETED USING SIMILAR DEVICE. SERIAL NUMBER USED WAS NOT PROVIDED. THERE WAS NO PATIENT HARM ON THE REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372404 ↗
• MalfunctionFeb 10, 2021Electrical Shorting; Electrical Shorting

  THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC PROCEDURE, THE MULTIDEBRIDER ANGLED HANDPIECE SHORTED OUT WHILE BEING USED WITH A GENERATOR. A CRUNCH SOUND WAS NOTED AND THE DEVICE STOPPED FUNCTIONING. THE USER CHANGED THE DISPOSABLE PORTIONS, TUBING, AND TIP AND FOUND IT WAS STILL NOT WORKING. ANOTHER ANGLED HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ANOMALIES WERE NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11311107 ↗
• MalfunctionJan 26, 2021Defective Device; Output Problem; Defective Device; Output Problem

  IT WAS REPORTED THAT THE DEVICE DOES NOT WORK AS INTENDED. AN ERROR RECEIVED STATING NEEDS TO RE PLUG AND UNPLUG THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11231367 ↗
• MalfunctionJan 12, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE HANDPIECE WAS NOT FUNCTIONING AS INTENDED. THE DIEGO DEVICE WAS SHOWING ALARM SAYING REBOOT SYSTEM WITH HANDPIECE, HOWEVER, WHEN TESTED WITH ANOTHER HANDPIECE, THE DIEGO DEVICE DID WORK WITH NO ISSUE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11157747 ↗
• MalfunctionJan 11, 2021Defective Device; Output Problem; Defective Device; Output Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE WAS FOUND NOT RECOGNIZING THE HANDPIECE. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11149064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123429. One submission often covers many models, so check the product and lot details in each record.

• Z-1182-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
• Z-1183-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
• Z-1181-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
• Z-1184-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
• Z-1186-2019 · Mar 8, 2019 · Terminated
  Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
• Z-1185-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
• Z-1178-2019 · Mar 8, 2019 · Terminated
  Olympus Diego Elite Console MDCONS 100
• Z-1180-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
• Z-1187-2019 · Mar 8, 2019 · Terminated
  Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
• Z-1179-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
• Z-1753-2015 · May 8, 2015 · Terminated
  Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngea
• Z-1752-2015 · May 8, 2015 · Terminated
  Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngea