DIEGO ELITERecalls & reported problems across all models
Gyrus ACMI, LLC · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one DIEGO ELITE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 73
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls
- 1
We found 18 models of DIEGO ELITE by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 73 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2020 and Mar 17, 2026 — classified as 21 injuries, 52 malfunctions.
The most frequently reported specific device problem is “Output Problem” (23 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
DIEGO ELITE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 3, 2017Open, Classified
"Chattering" when cutting burrs are used in bone.
Z-1337-2018 · names 3 of these models · Recall details · FDA record ↗
Most reported DIEGO ELITE problems
Device problems
- Output Problem23
- Defective Device11
- Adverse Event Without Identified Device or Use Problem10
- Mechanical Problem8
- Break4
- Manufacturing, Packaging or Shipping Problem4
- Overheating of Device4
- No Device Output3
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- No Consequences Or Impact To Patient12
- No Patient Involvement9
- Hemorrhage/Blood Loss/Bleeding8
- Unspecified Tissue Injury4
- Eye Injury2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Pain1
DIEGO ELITE models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Diego Elite MBUR6060FRCVBUR, EAR, NOSE AND THROAT1 recall2 reports
- DIEGO ELITE MBUR5060FRCVBUR, EAR, NOSE AND THROAT1 recall0 reports
- Diego Elite MBUR7060FRCVBUR, EAR, NOSE AND THROAT1 recall0 reports
- DIEGO ELITE MDCONS100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES26 reports
- DIEGO ELITE MDHP100AELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- DIEGO ELITE MDFS100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- DIEGO ELITE MDHP100SELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- DIEGO ELITE TS101DCELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Diego Elite MDHP200DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE3 reports
- DIEGO ELITE BUR3070DBBUR, EAR, NOSE AND THROAT2 reports
- Diego Elite MDSSADRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
- Diego Elite MDASADRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE1 report
- Diego Elite HSDHP200TRAYTRAY, SURGICAL, INSTRUMENT1 report
- DIEGO ELITE BB2000SAELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- DIEGO ELITE BB4040SSELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- DIEGO ELITE BUR4070DTBUR, EAR, NOSE AND THROAT1 report
- Diego Elite NCGRIPELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- DIEGO ELITE SB4040RCBUR, EAR, NOSE AND THROAT1 report
Recent DIEGO ELITE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Packaging Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24619029 ↗MalfunctionFeb 13, 2026Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE DIEGO ELITE TUBESET DECLOG HAD BROWN OILY FLUID ON THE VALVE TO THE BALLOON.THE ISSUE OCCURRED DURING THE DEVICE'S SETUP ¿ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24334948 ↗MalfunctionFeb 12, 2026Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321319 ↗MalfunctionJan 6, 2026Manufacturing, Packaging or Shipping Problem
NO ADDITIONAL INFORMATION FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974205 ↗MalfunctionJan 6, 2026Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE DIEGO ELITE TUBESET DECLOG HAD STAINING/RESIDUE INSIDE THE STERILE PACKAGING. THE ISSUE OCCURRED DURING THE DEVICE'S SETUP ¿ INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23974198 ↗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, 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 ↗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 ↗
Other Gyrus ACMI, LLC products
- SOLTIVE16 models · 867 reports · 17 recalls
- Olympus27 models · 518 reports · 21 recalls
- SHOCKPULSE11 models · 580 reports · 5 recalls
- EZDilate7 models · 33 reports · 6 recalls
- Spiration Valve System10 models · 242 reports · 1 recall
- BiCOAG4 models · 36 reports · 5 recalls
- USA Elite24 models · 78 reports · 3 recalls
- M3 Gold5 models · 30 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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