DIEGO ELITE MDHP100SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925027756), received between Jan 25, 2021 and Dec 4, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED VIA A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY, THE DIEGO ELITE WAS USED FOR SOFT TISSUE SHAVING OF THE HEAD AND NECK. THE DEVICE HAD TECHNICAL ISSUES AND DID NOT ADEQUATELY COAGULATE THE BONE. THE PROCEDURE WAS CONTINUED WITHOUT USE OF THE DEVICE. AN ORBITAL INJURY OCCURRED WITHIN 2 TO 7 DAYS AFTER THE PROCEDURE IN WHICH ADDITIONAL MEDICATION WAS USED FOR CLINICAL MANAGEMENT. THE PATIENT WAS DISCHARGED HOME FULLY RECOVERED. THE PATIENT HAD COMORBIDITIES THAT MAY HAVE CONTRIBUTED TO THE ORBITAL INJURY.

  Patient problems: Eye Injury

  MAUDE report 18264025 ↗
• MalfunctionFeb 23, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE DEVICE IS NOT FUNCTIONING AS INTENDED. AN ERROR OCCURRED WHEN PLUGGED IN. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11366951 ↗
• MalfunctionFeb 18, 2021Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE DEVICE DID NOT WORK AS INTENDED. THE BURR HAD INITIALLY WORKED, THEN EVENTUALLY STOPPED COMPLETELY. A CONSOLE AND TWO (2) SEPARATE HANDPIECES WERE USED WITH THE BURR FOR TESTING, HOWEVER THE ISSUE REMAINED. THE DRILL WAS TAKEN FROM THE HANDPIECE AND IT WAS OBSERVED THAT PART OF THE WHITE PIECE OF PLASTIC IN THE DRILL WHERE THE DRILL IS INSERTED INTO THE HANDPIECE WAS CHIPPED UP. THE PROCEDURE WAS PROLONGED OVER AN HOUR AND WAS THEN ABORTED DUE TO A LACK OF BURRS. THE PATIENT HAD TO BE RESCHEDULED FOR A NEW PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. THE USER FACILITY LATER REPORTED THAT THE REASON WHY THE BURRS BROKE WAS THAT THEY WERE USED ON A PATIENT WITH AN OSTEOMA. THE BONE TISSUE WAS TOO HARD FOR THE BURR TO DRILL AWAY. THE ROTATION SPEED OF THE SHAVER BECAME TOO SMALL TO HANDLE THIS. THE CUSTOMER ACKNOWLEDGED THAT BURRS WERE USED IN A PROCEDURE THEY ARE NOT INTENDED TO BE USED IN. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(6) AND (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11344499 ↗
• MalfunctionFeb 18, 2021Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS), THE DEVICE DID NOT WORK AS INTENDED. THE BURR HAD INITIALLY WORKED, THEN EVENTUALLY STOPPED COMPLETELY. A CONSOLE AND TWO (2) SEPARATE HANDPIECES WERE USED WITH THE BURR FOR TESTING, HOWEVER THE ISSUE REMAINED. THE DRILL WAS TAKEN FROM THE HANDPIECE AND IT WAS OBSERVED THAT PART OF THE WHITE PIECE OF PLASTIC IN THE DRILL WHERE THE DRILL IS INSERTED INTO THE HANDPIECE WAS CHIPPED UP. THE PROCEDURE WAS PROLONGED OVER AN HOUR AND WAS THEN ABORTED DUE TO A LACK OF BURRS. THE PATIENT HAD TO BE RESCHEDULED FOR A NEW PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WAS INSPECTED PRIOR TO THE PROCEDURE AND NO DAMAGE OR ABNORMALITIES WERE OBSERVED. THE USER FACILITY LATER REPORTED THAT THE REASON WHY THE BURRS BROKE WAS THAT THEY WERE USED ON A PATIENT WITH AN OSTEOMA. THE BONE TISSUE WAS TOO HARD FOR THE BURR TO DRILL AWAY. THE ROTATION SPEED OF THE SHAVER BECAME TOO SMALL TO HANDLE THIS. THE CUSTOMER ACKNOWLEDGED THAT BURRS WERE USED IN A PROCEDURE THEY ARE NOT INTENDED TO BE USED IN. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIERS; (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11344273 ↗
• MalfunctionJan 25, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WAS FOUND NOT FUNCTIONING AS INTENDED. THE DEVICE WAS PLUGGED IN AND DID NOT WORK. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11225138 ↗

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-1185-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
• 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-1179-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
• 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-1182-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
• Z-1186-2019 · Mar 8, 2019 · Terminated
  Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
• Z-1187-2019 · Mar 8, 2019 · Terminated
  Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
• Z-1181-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
• 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