DIEGO ELITE MDFS100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821925027787), received between Jan 15, 2021 and Nov 20, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE DIEGO ELITE MULTIDEBRIDER FOOTSWITCH WAS NOT RESPONDING. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE CUSTOMER HAD EXPERIENCED AN ISSUE A FEW DAYS BEFOREHAND AND WAS WIGGLING THE WIRE BUT NOW THERE WAS NO RESPONSE AT ALL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18177601 ↗
• InjuryJul 26, 2023Blocked Connection; Blocked Connection

  OLYMPUS FURTHER RECEIVED INFORMATION THAT THE INTENDED PROCEDURE WAS FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE BLEEDING WAS RESOLVED BY CAUTERY. THE DEVICE WAS INSPECTED BEFORE USE WITH NO VISIBLE ISSUES. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17396221 ↗
• MalfunctionMay 31, 2023Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THE FOOT PEDAL WENT ALL THE WAY DOWN. PER THE REPORT, THE SPRING FOR THE SHAFT SUSPECTED TO BE BROKEN. THE ISSUE FOUND AT PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028809 ↗
• InjuryFeb 23, 2023Intermittent Continuity; Unexpected Shutdown; Intermittent Continuity; Unexpected Shutdown

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A MULTIDEBRIDER FOOTSWITCH DURING AN UNSPECIFIED PROCEDURE WHILE REMOVING POLYPS, THE FOOT SWITCH WAS INTERMITTENT AND THEN LOST ALL POWER. THE PHYSICIAN WAS ABLE TO USE A MANUAL INSTRUMENT TO REMOVE THE POLYP AND THERE WAS NO IMPACT TO THE PATIENT'S PROCEDURE OUTCOME. HOWEVER, THE FOOT SWITCH ISSUE CAUSED A PROCEDURE DELAY OF AROUND 30 MINUTES WHILE ATTEMPTING TO REMEDY THE SITUATION. PATIENT IDENTIFIER (B)(6) IS FOR THE MULTIDEBRIDER POWER CONSOLE. PATIENT IDENTIFIER (B)(6) IS FOR THE MULTIDEBRIDER FOOTSWITCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432617 ↗
• MalfunctionAug 2, 2022Electrical /Electronic Property Problem; Mechanical Problem; Electrical /Electronic Property Problem; Mechanical Problem

  IT WAS REPORTED THAT IN THE MIDDLE OF A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE IN NOSE, CUSTOMER TRIED TO STOP THE ROTATION OF DIEGO'S TERMINAL BY RELEASING THE FOOTSWITCH. HOWEVER; THE BLADE KEPT ON ROTATING AT LOWER REVOLUTIONS EVEN THOUGH THE FOOTSWITCH WAS NOT PRESSED DOWN. IT DID NOT CAUSE ANY DAMAGE TO PATIENT AS IT WAS REMOVED IN TIME. THE DEVICE WAS REPLACED. THE INTENDED PROCEDURE WAS COMPLETED WITH A BACKUP FOOTSWITCH. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15143724 ↗
• MalfunctionJan 15, 2021Defective Device

  IT WAS REPORTED THAT DURING AN ASSET RETURN INSPECTION THE DEVICE WAS FOUND WITH FAULTY SWITCH. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11181359 ↗

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-1186-2019 · Mar 8, 2019 · Terminated
  Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
• Z-1178-2019 · Mar 8, 2019 · Terminated
  Olympus Diego Elite Console MDCONS 100
• 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-1184-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
• Z-1181-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
• Z-1187-2019 · Mar 8, 2019 · Terminated
  Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
• Z-1185-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
• Z-1180-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
• Z-1179-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
• 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
• 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