USA EliteRecalls & reported problems across all models
Gyrus ACMI, LLC · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one USA Elite model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 3
We found 24 models of USA Elite by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2020 and Mar 24, 2026 — classified as 6 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Break” (46 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
USA 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.
- Jun 18, 2025Open, Classified
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2146-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
- Jun 18, 2025Open, Classified
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2145-2025 · Root cause: Packaging change control · Recall details · FDA record ↗
- Oct 2, 2023Open, Classified
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Z-0568-2024 · Root cause: Labeling Change Control · names 2 of these models · Recall details · FDA record ↗
Most reported USA Elite problems
Device problems
- Break46
- Crack11
- Detachment of Device or Device Component5
- Mechanical Problem5
- Arcing of Electrodes4
- Defective Device3
- Fracture3
- Sparking3
Patient problems
- No Clinical Signs, Symptoms or Conditions71
- Foreign Body In Patient3
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
USA Elite models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- USA Elite MLE-24-012ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall9 reports
- USA Elite RBELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 recall1 report
- USA Elite 190-NRSHysteroscope (And Accessories)1 recall0 reports
- USA Elite 191-NRSEVACUATOR, GASTRO-UROLOGY1 recall0 reports
- USA Elite EIS-HCF25Hysteroscope (And Accessories)25 reports
- USA Elite EMRS-26BHysteroscope (And Accessories)9 reports
- USA Elite E123-OHysteroscope (And Accessories)4 reports
- USA Elite REXERIS-CF25OBTURATOR, FOR ENDOSCOPE4 reports
- USA Elite E8215FORCEPS, GENERAL & PLASTIC SURGERY3 reports
- USA Elite EMRS-26Hysteroscope (And Accessories)3 reports
- USA Elite REXEIS-CFR-27Hysteroscope (And Accessories)3 reports
- USA Elite EMRS-24Hysteroscope (And Accessories)2 reports
- USA Elite EMRS-24BHysteroscope (And Accessories)2 reports
- USA Elite REXEIS-HCF25Hysteroscope (And Accessories)2 reports
- USA Elite MLE-28-012ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL2 reports
- USA Elite E8213FORCEPS, GENERAL & PLASTIC SURGERY1 report
- USA Elite EIS-CFR-27Hysteroscope (And Accessories)1 report
- USA Elite EIS-HCF27Hysteroscope (And Accessories)1 report
- USA Elite EIWECYSTOURETHROSCOPE1 report
- USA Elite E117-OHysteroscope (And Accessories)1 report
- USA Elite E121-OHysteroscope (And Accessories)1 report
- USA Elite K-SBUrethrotome1 report
- USA Elite REXERIS-CF27Hysteroscope (And Accessories)1 report
- USA Elite DACELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL1 report
Recent USA Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE HAD A INSTRUMENT TIP IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24681606 ↗MalfunctionMar 23, 2026Crack
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE EXHIBITED THE CRACK BEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24659931 ↗MalfunctionFeb 3, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE HYSTEROSCOPE (AND ACCESSORIES) HAD A DAMAGED INSTRUMENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245514 ↗MalfunctionDec 26, 2025Break; Break
IT WAS REPORTED THAT THE HYSTEROSCOPE HAD A BROKEN CERAMIC TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23899000 ↗MalfunctionNov 19, 2025Material Deformation; Material Deformation
IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE HYSTEROSCOPE EXHIBITED DEFORMED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23601224 ↗MalfunctionApr 24, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THE ELITE RIGID OPTICAL GRASPING FORCEPS EXPERIENCED OPTICAL TEETH ARE NOT LINING UP ISSUE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902037 ↗MalfunctionMar 26, 2025Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BROKEN TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21701605 ↗MalfunctionMar 20, 2025Break; Break
IT WAS REPORTED THAT THE PLASTIC TOP OF THE SUBJECT DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657343 ↗MalfunctionFeb 22, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD A CHIP IN THE TIP AND COULD NOT GET THE TIP IN THE OUTER SHEATH DURING SET UP / INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21440523 ↗MalfunctionJan 15, 2025Break; Break
IT WAS REPORTED THE SUBJECT DEVICE HAD A BROKEN TIP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21162374 ↗MalfunctionNov 13, 2024Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RESECTOSCOPE EXHIBITED DENTED PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20677561 ↗InjuryOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING CYSTOSCOPY WITH DIRECT VISION INTERNAL URETHROTOMY (DVIU) , THE KNIFE FELL OFF IN THE PATIENT WHILE INCISING A URETHRAL STRICTURE. A PROCEDURE DELAY OCCURRED, BUT THE TIME FRAME WAS UNKNOWN. A CT SCAN WAS USED TO VISUALIZE THE KNIFE, AND A FOLLOW UP CYSTOSCOPY WITH DVIU WAS PERFORMED TO RETRIEVE THE KNIFE SUCCESSFULLY 8 DAYS LATER. INTEROPERATIVE FLUOROSCOPY WAS UTILIZED DURING THE FOLLOW UP CASE AS WELL TO AID IN KNIFE RETRIEVAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER THE FIRST PROCEDURE, BUT THE TIME FRAME WAS UNKNOWN. IT WAS STATED THAT THE SECOND PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Foreign Body In Patient
MAUDE report 20351284 ↗MalfunctionAug 26, 2024Break; Break
IT WAS REPORTED THE RESECTOSCOPE METAL SHEATH TIP BROKE OFF AND FELL WITHIN THE PATIENT ANATOMY DURING AN UNSPECIFIED PROCEDURE. THE TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20072675 ↗MalfunctionAug 6, 2024Crack; Crack
THE CUSTOMER REPORTED TO OLYMPUS THE CYSTOURETHROSCOPE STANDARD OBTURATOR, 23FR TIP IS CRACKED. THE REPORTED ISSUE WAS DISCOVERED DURING PREPARATION OF USE FOR AN UNKNOWN PROCEDURE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19924487 ↗MalfunctionJul 24, 2024Break; Break
IT WAS REPORTED, THE SHEATH'S CERAMIC TIP WAS BROKE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822147 ↗
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
- M3 Gold5 models · 30 reports · 2 recalls
- PK TECHNOLOGY10 models · 24 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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