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Frigitronics CE-2000Recalls & reported problems

Coopersurgical, Inc. · Cryosurgical System · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888937009422), received between Oct 2, 2021 and Oct 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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

  • Difficult to Remove1
  • Leak/Splash1
  • Output Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionOct 2, 2021Leak/Splash; Difficult to Remove; Output Problem

    CUSTOMER STATED: "PROBE WOULD NOT UNFREEZE TO REMOVE FROM PATIENT'S EYE". CE-2000 OPTHALMIC CRYO SYSTEM DIG E-COMPLAINT (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 12566463 ↗

Other Unit, Cryotherapy, Ophthalmic devices

All Unit, Cryotherapy, Ophthalmic devices →

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