DIEGO ELITE MDCONS100Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00821925027770), received between Jan 13, 2021 and Oct 18, 2024 — classified as 12 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Output Problem” (11 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC DISC NASAL SURGERY (TYPE IV), NASAL SEPTUM CORRECTION, AND INFERIOR TURBINATE MUCOSAL RESECTION, THE SUBJECT DEVICE SUDDENLY STOPPED WORKING AND THE SCREEN WOULD NOT COME UP. THE DEVICE WAS RESTARTED, BUT THE SCREEN TURNED RAINBOW-COLORED AND WOULD NOT COME UP. THERE WAS NO ERROR CODE GENERATED. THE PROCEDURE WAS COMPLETED WITH A NON-OLYMPUS DEVICE AFTER A 1-HOUR DELAY. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482964 ↗
• InjuryDec 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A POST-MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY, THE DIEGO ELITE WAS USED FOR A LARYNGEAL PROCEDURE FOR RECURRENT RESPIRATORY PAPILLOMA, LESION DEBULKING, POLYPECTOMY. THE DEVICE WAS USED TO CUT, COAGULATE, AND REMOVE SOFT TISSUE AND PERFORMED ADEQUATELY. PERIPROCEDURAL INTRAOPERATIVE BLOOD LOSS OCCURRED REQUIRING RE-HOSPITALIZATION. THE PATIENT MADE A FULL RECOVERY TO BASELINE AT THE TIME OF HOSPITAL DISCHARGE. THE PATIENT HAD KNOWN USE OF ANTICOAGULANTS THAT MAY HAVE ATTRIBUTED TO THE INTRAOPERATIVE BLOOD LOSS. PERIPROCEDURAL BLEEDING OCCURRED, AND NO ADDITIONAL TREATMENT WAS REQUIRED. PAIN OCCURRED 1 TO 24 HOURS AFTER THE PROCEDURE AND REQUIRED ADDITIONAL MEDICATION. THE PATIENT MADE A FULL RECOVERY TO BASELINE AT THE TIME OF HOSPITAL DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 18298628 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA DIEGO ELITE HCP RETROSPECTIVE CHART REVIEW PMCF SURVEY, THE PATIENT EXPERIENCED A BLEEDING 1-24 HOURS OF AN ADENOIDECTOMY/TONSILLECTOMY PROCEDURE WHILE USING A MULTIDEBRIDER POWER CONSOLE. ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DISCHARGED FULLY RECOVERED TO BASELINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18297169 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA DIEGO ELITE HCP RETROSPECTIVE CHART REVIEW PMCF SURVEY, THE PATIENT EXPERIENCED A MUCOSAL INJURY WITHIN 2-7 DAYS OF AN ADENOIDECTOMY/TONSILLECTOMY PROCEDURE WHILE USING A MULTIDEBRIDER POWER CONSOLE. ADDITIONAL SURGICAL INTERVENTION, RE-HOSPITALIZATION AND ADDITIONAL MEDICATION WAS REQUIRED. THE PATIENT WAS DISCHARGED FULLY RECOVERED TO BASELINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18297053 ↗
• InjuryDec 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER REPORTED IN A POST MARKET CLINICAL FOLLOW UP STUDY THAT WHEN USING A DIEGO ELITE DURING SOFT TISSUE DRILLING, A PATIENT EXPERIENCED MUCOSAL INJURY WITHIN OR EQUAL TO AN HOUR POST PROCEDURALLY. THE MUCOSAL INJURY WAS MANAGED WITH RE-HOSPITALIZATION. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT DRILL ADEQUATELY DUE TO TECHNICAL ISSUES, WHICH WAS DESCRIBED AS "NESSUNO" WITHOUT OTHER DETAILS. THE PHYSICIAN PROCEEDED WITHOUT USE OF THE DEVICE OR ANY OTHER DEVICE FOR DRILLING. THE EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE (ADENOIDECTOMY/TONSILLECTOMY) AND WAS COMPLETED WITHOUT USING THIS DEVICE. THE PATIENT FULLY RECOVERED TO BASELINE AT TIME OF HOSPITAL DISCHARGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18293004 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER REPORTED VIA DIEGO ELITE HCP RETROSPECTIVE CHART REVIEW PMCF SURVEY, WHEN USING A MULTIDEBRIDER POWER CONSOLE DURING SOFT SHAVING OF THE HEAD AND NECK, A PATIENT EXPERIENCED PERIPROCEDURAL BLEEDING. THE EXTENT OF THE BLEEDING IS UNKNOWN, HOWEVER; ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO MANAGE THE BLEEDING. THE PATIENT FULLY RECOVERED TO BASELINE AT TIME OF HOSPITAL DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18291193 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A POST MARKET CLINICAL FOLLOW-UP (PMCF) SURVEY, THE DIEGO ELITE WAS USED FOR A SOFT TISSUE SHAVING OF THE HEAD AND NECK AND DID NOT COAGULATE ADEQUATELY DUE TO PATIENT FACTORS UNRELATED TO THE DEVICE. THEREFORE, A SUTURE TIE WAS USED. THE DEVICE DID ADEQUATELY DEBRIDE DURING THE PROCEDURE. PERIPROCEDURAL BLEEDING OCCURRED THAT WAS MANAGED CLINICALLY BY AN ADDITIONAL SURGICAL INTERVENTION. THE PATIENT MADE A FULL RECOVERY TO BASELINE AT THE TIME OF HOSPITAL DISCHARGE. THERE WERE NO KNOWN PATIENT CO-MORBIDITIES AT THE TIME OF PROCEDURE THAT MAY HAVE ATTRIBUTED TO THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18268145 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 AND ADEQUATELY DEBRIDED DURING THE PROCEDURE. PERIPROCEDURAL BLEEDING OCCURRED THAT REQUIRED ADDITIONAL SURGICAL INTERVENTION. IT WAS STATED THAT THE DEVICE ADEQUATELY DEBRIDED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME FULLY RECOVERED. THERE WERE NO KNOWN PATIENT COMORBIDITIES AT THE TIME OF PROCEDURE THAT MAY HAVE ATTRIBUTED TO THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18268071 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 ADEQUATELY COAGULATED BONE AND SOFT TISSUE DURING THE PROCEDURE. THE FOLLOWING ADVERSE EVENTS OCCURRED: BLEEDING: OCCURRED 1 TO 24 HOURS AFTER THE PROCEDURE AND REQUIRED RE-HOSPITALIZATION. THE PATIENT MADE A PARTIAL RECOVERY TO BASELINE. THERE WERE PATIENT COMORBIDITIES AT THE TIME OF PROCEDURE THAT MAY HAVE ATTRIBUTED TO THE BLEEDING. MUCOSAL INJURY: OCCURRED LESS THAN 1 HOUR AFTER THE PROCEDURE AND REQUIRED ADDITIONAL MEDICATION. THE PATIENT MADE A PARTIAL RECOVERY TO BASELINE. THERE WERE PATIENT COMORBIDITIES AT THE TIME OF PROCEDURE THAT MAY HAVE ATTRIBUTED TO THE MUCOSAL INJURY. NASAL SYMPTOMS: OCCURRED LESS THAN 1 HOUR AFTER THE PROCEDURE AND REQUIRED RE-HOSPITALIZATION. THE PATIENT MADE A PARTIAL RECOVERY TO BASELINE. THERE WERE PATIENT COMORBIDITIES AT THE TIME OF PROCEDURE THAT MAY HAVE ATTRIBUTED TO THE NASAL SYMPTOMS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 18263981 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use 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 DIEGO ELITE PERFORMED ADEQUATELY TO CUT, COAGULATE, DRILL, DEBRIDE, AND REMOVE TISSUE FOR BONE AND SOFT TISSUE. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: BLEEDING: THE BLEEDING OCCURRED 2 TO 7 DAYS POST PROCEDURE AND THE PATIENT WAS RE-HOSPITALIZED. THE PATIENT MADE A PARTIAL RECOVERY TO BASELINE. THERE WERE KNOWN COMORBIDITIES THAT MAY HAVE ATTRIBUTED TO THE BLEEDING. MUCOSAL INJURY: THE MUCOSAL INJURY OCCURRED 1 TO 24 HOURS AFTER THE PROCEDURE AND WAS MANAGED CLINICALLY WITH ADDITIONAL MEDICATION. THE PATIENT MADE A FULL RECOVERY TO BASELINE AT THE TIME OF HOSPITAL DISCHARGE. THERE WERE KNOWN COMORBIDITIES THAT MAY HAVE ATTRIBUTED TO THE MUCOSAL INJURY. NASAL SYMPTOMS: NASAL SYMPTOMS OCCURRED 8 TO 14 DAYS AFTER THE PROCEDURE REQUIRING REHOSPITALIZATION AND ADDITIONAL MEDICATION. THE PATIENT MADE A PARTIAL RECOVERY TO BASELINE. THERE WERE KNOWN COMORBIDITIES THAT MAY HAVE ATTRIBUTED TO THE NASAL SYMPTOMS. ORBITAL INJURY: ORBITAL INJURY OCCURRED 2 TO 7 DAYS AFTER THE PROCEDURE THAT REQUIRED RE-HOSPITALIZATION. THE PATIENT MADE A FULL RECOV

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 18243781 ↗
• InjuryFeb 24, 2023Intermittent Continuity; Unexpected Shutdown; Intermittent Continuity; Unexpected Shutdown

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A MULTIDEBRIDER POWER CONSOLE 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 16439072 ↗
• InjuryJan 17, 2023Defective Device; Defective Device

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE WITH THE SHORT MASTOID ATTACHMENT, BECAME SUFFICIENTLY HOT TO BURN THROUGH METAL AND CAUSED SEVERE, FIRST-DEGREE BURNS WITH BLISTERING TO THE PHYSICIAN'S TWO FINGERS DURING A THERAPEUTIC MASTOID PROCEDURE FOR CHOLESTEATOMA. THE BURNS WERE TREATED WITH COLD APPLICATION. THE PHYSICIAN HAD ONLY BEEN USING IT FOR LESS THAN A MINUTE. THE HAND PIECE REPORTEDLY STARTED SMOKING AND SMELLED LIKE BURNING METAL SIMILAR TO A FIRED GUN. IN ADDITION, THE BURR PIECE BROKE INSIDE THE HANDPIECE. THE PHYSICIAN ATTEMPTED TO USE ANOTHER OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE BUT THERE WERE MORE "ISSUES" NOTED AND THE DIEGO ELITE SYSTEM CONSOLE REPORTEDLY "MALFUNCTIONED" AS WELL. THE CUSTOMER BELIEVED THAT THE SECOND HANDPIECE WAS INCORRECTLY ATTACHED TO THE CONSOLE AND ATTRIBUTED THE ISSUE TO EITHER THE CONSOLE OR USER ERROR. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED. CASE WITH PATIENT IDENTIFIER: (B)(6) REPORTS THE FIRST OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE. CASE WITH PATIENT IDENTIFIER: (B)(6) REPORTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186216 ↗
• MalfunctionJun 22, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE CUTS OUT IN MID USE. THE ISSUE OCCURRED DURING A THERAPEUTIC FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY). ACCORDING TO THE DOCTOR (USER), THE OPERATION WAS ABANDONED AS THE MACHINE CUTS OUT AND COULD NOT BE USED AND THAT THE ONLY PROBLEM IS THAT THE PATIENT WILL NEED TO RETURN TO HAVE THE PROCEDURE DONE AGAIN AT ANOTHER DATE. THE REPORTER REPORTED NO PATIENT HARM OR INJURY AND NO MEDICAL INTERVENTION REPORTED AS A RESULT OF THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14767136 ↗
• MalfunctionJun 20, 2022Output Problem; Key or Button Unresponsive/not Working; Output Problem; Key or Button Unresponsive/not Working

  IT WAS REPORTED DURING A THERAPEUTIC FESS (FUNCTIONAL ENDOSCOPIC SINUS SURGERY) PROCEDURE; THE UNIT WAS FUNCTIONAL THROUGHOUT THE PROCEDURE BUT MALFUNCTIONED AT THE END. ACCORDING TO THE REPORTER, THE SUCTION BUTTON NON FUNCTIONAL FROM THE CONSOLE , HANDPIECE AND FOOT PEDAL THEN FAILED TOWARDS END OF SURGERY. THE SURGEON COMPLETED THE SURGERY USING CONVENTIONAL SURGICAL TECHNIQUES AND THE SURGERY WAS SUCCESSFUL. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749819 ↗
• MalfunctionJun 8, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DIEGO ELITE CONSOLE HAD BECOME EXTREMELY HOT DURING PROCEDURE AND THEN THE DEVICE COMPLETELY POWERED DOWN. ALL POWER WAS CUT OUT AND THEY HAVE NOT BEEN ABLE TO RESTART THE DEVICE. THE DEVICE HAVE TAKEN OUT OF CLINICAL USE. ACCORDING TO THE REPORTER, THE PROCEDURE HAD TO BE ABANDONED BUT THE PATIENT IS FINE IN TERMS OF HEALTH (NO INJURY/INFECTION), ONLY INCONVENIENCE OF HAVING TO GO THROUGH THE PROCEDURE AGAIN. ACCORDING TO THE REPORTER, THE CUSTOMER WAS PROVIDED A LOANER NEEDED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14640095 ↗
• MalfunctionMay 14, 2021Use of Device Problem; Use of Device Problem

  DURING PREPARATION FOR USE, THE MAIN CONSOLE WAS NOT FUNCTIONING AS INTENDED AS THE CONSOLE REPORTEDLY HAD TO BE REBOOTED THREE TIMES TO GET THE HANDPIECE DEVICE TO WORK. THERE WAS NO PATIENT INJURY OR ADVERSE OUTCOME REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827084 ↗
• MalfunctionApr 29, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE IS NOT ACTIVATING WITH THE HANDPIECE. THE SCREEN WILL NOT ACTIVATE AND THE BUTTON ARE NOT RESPONDING. THE PUMP HAS REDUCE FUNCTION. IT HAPPENS INTERMITTENTLY .THE ISSUE FOUND DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750433 ↗
• MalfunctionApr 23, 2021Failure to Power Up; Output Problem; Intermittent Energy Output; Failure to Power Up; Output Problem; Intermittent Energy Output

  A REPORT OF MAIN CONSOLE NOT FUNCTIONING AS INTENDED, SYSTEM IS NOT BOOTING UP WITH BIPOLAR MODE WORKING INTERMITTENTLY DURING PREPARATION FOR USE WAS REPORTED. NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713079 ↗
• MalfunctionFeb 18, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE CONSOLE NOT FUNCTIONING AS INTENDED, FOOT PEDAL CONNECTION ISSUE. THE CONSOLE WOULD NOT READ THE FOOT PEDAL. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11345198 ↗
• 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 11344227 ↗
• MalfunctionJan 29, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF A SEPTORHINOPLASTY PROCEDURE THE DEVICE WILL SHOW GREEN WHEN THEY PRESS THE FOOT PEDAL HOWEVER, IT GOES OUT RIGHT AWAY AND NO ACTIVATION TO THE HANDPIECE WAS OBSERVED. THERE WAS AN APPROXIMATELY 20 MINUTES DELAY INTO THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD WITH DIFFERENT DEVICE. THE SERIAL NUMBER USED WAS NOT PROVIDED. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11254732 ↗
• MalfunctionJan 26, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE IS NOT FUNCTIONING AS INTENDED. THE BIPOLAR FUNCTION DOES NOT RECOGNIZED BY THE CONSOLE. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11232508 ↗
• MalfunctionJan 18, 2021Defective Alarm; Output Problem; Defective Alarm; Output Problem

  IT WAS REPORTED THAT THE DEVICE WAS OBSERVED TO BE NOT FUNCTIONING AS INTENDED. THE ISSUE WAS FIRST OBSERVED AT THE BEGINNING OF AN UNSPECIFIED PROCEDURE. THERE WAS A DELAY IN THE PROCEDURE HOWEVER THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. SERIAL: (B)(4) WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR IMPACT REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11189405 ↗
• MalfunctionJan 18, 2021Defective Device; Output Problem; Defective Device; Output Problem

  IT WAS REPORTED THAT DURING AN ASSET RETURN INSPECTION THE DEVICE WAS OBSERVED WITH TOUCH SCREEN STAYS GRAY AND DOES NOT RESPOND. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11189338 ↗
• MalfunctionJan 13, 2021Output Problem; Output Problem

  IT WAS REPORTED THAT IN THE MIDDLE OF A SINUS SURGERY PROCEDURE THE DEVICE WAS OBSERVED TO BE NOT FUNCTIONING. THE USER IS HAVING A LONG BOOT AND ACTIVATION ISSUES. THE INTENDED PROCEDURE WAS COMPLETED WITHOUT ANY DELAY. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THE SERIAL NUMBER OF THE DEVICE USED TO COMPLETE THE CASE WAS NOT PROVIDED. THERE WAS NO PATIENT HARM OR INJURY REPORTED. NO USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11166006 ↗

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-1179-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
• Z-1180-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
• 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-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-1184-2019 · Mar 8, 2019 · Terminated
  Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
• 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-1186-2019 · Mar 8, 2019 · Terminated
  Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
• 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