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CER-1Recalls & reported problems

Medivators Inc. · CER-1 · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00677964021695), received between Sep 7, 2018 and Sep 7, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Off-Label Use” (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

  • Off-Label Use1
  • Use of Incorrect Control/Treatment Settings1

Patient problems

  • Chemical Exposure1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjurySep 7, 2018Use of Incorrect Control/Treatment Settings; Off-Label Use; Use of Incorrect Control/Treatment Settings; Off-Label Use

    IT WAS REPORTED THAT A FACILITY WAS REPROCESSING ENDOSCOPES WITH THEIR CER-1 AUTOMATIC ENDOSCOPE REPROCESSOR (AER) WITH THE INCORRECT AMOUNT OF RINSES PER THE HIGH-LEVEL DISINFECTANT LABELING AND AER INSTRUCTIONS-FOR-USE. THE FACILITY WAS USING CIDEX OPA HLD WHICH REQUIRES 3 RINSES BUT THEIR AER WAS SET UP WITH 2 RINSES. THERE IS POTENTIAL THAT ENDOSCOPES MAY HAVE CONTAINED HLD RESIDUAL AFTER REPROCESSING WHICH COULD CAUSE CHEMICAL COLITIS OR ADVERSE REACTIONS TO PATIENTS.

    Patient problems: Chemical Exposure; No Known Impact Or Consequence To Patient

    MAUDE report 7857564 ↗

Other Washer, Cleaner, Automated, Endoscope devices

All Washer, Cleaner, Automated, Endoscope devices →

Sources and updates

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