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CER-2 OptimaRecalls & reported problems

Medivators Inc. · CER-2 Optima · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00677964052491), received between Oct 10, 2017 and Oct 10, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Maintenance Does Not Comply To Manufacturers Recommendations” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Maintenance Does Not Comply To Manufacturers Recommendations1
  • Misconnection1

Patient problems

  • Exposure to Body Fluids1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 10, 2017Misconnection; Maintenance Does Not Comply To Manufacturers Recommendations; Misconnection; Maintenance Does Not Comply To Manufacturers Recommendations

    MEDIVATORS CLINICAL EDUCATION SPECIALIST REPORTED THAT A FACILITY WAS REQUESTING A FULL IN-SERVICE TRAINING FOR THEIR CER-2 AUTOMATED ENDOSCOPE REPROCESSORS AFTER A DAMAGED HOOKUP WAS USED DURING SCOPE REPROCESSING. DUE TO THE DAMAGED HOOKUP, THERE IS POTENTIAL THAT SCOPES WERE NOT PROPERLY HIGH LEVEL DISINFECTED. THE FACILITY HAS IDENTIFIED 2 PATIENTS WHO HAD PROCEDURES PERFORMED WITH SCOPES THAT WERE REPROCESSED WITH THE DAMAGED HOOKUP.

    Patient problems: Exposure to Body Fluids

    MAUDE report 6935783 ↗
  • InjuryOct 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPORTED NOTICING THE METRICIDE OPA PLUS HIGH LEVEL DISINFECTANT USED IN THEIR CER 2 OPTIMA AUTOMATED ENDOSCOPE REPROCESSOR HLD RESERVOIR WAS CLOUDY IN APPEARANCE. IT WAS SUSPECTED THAT SOMEONE ACCIDENTALLY TOPPED OFF THE DISINFECTANT RESERVOIR WITH METRIZYME DETERGENT. THERE IS POTENTIAL FOR PATIENT ADVERSE EFFECTS SUCH AS CROSS CONTAMINATION IF SCOPES ARE NOT PROPERLY HIGH LEVEL DISINFECTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6934997 ↗

Other Washer, Cleaner, Automated, Endoscope devices

All Washer, Cleaner, Automated, Endoscope devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.