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Frigitronics 124Recalls & reported problems

Coopersurgical, Inc. · Retinal, Straight Probe. Tip: 2.5mm diameter. Shaft: 38mm length x 2.5mm diameter. · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888937004144), received between Jun 4, 2021 and Oct 1, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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

  • Defective Device1
  • Excess Flow or Over-Infusion1
  • Leak/Splash1
  • Mechanical Problem1
  • Temperature Problem1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 1, 2021Defective Device

    CUSTOMER STATED: "PROBE WOULD FORM AN ICE BALL BUT WHEN APPLYING TO A PATIENT IT WOULD NOT CONTINUE TO FORM THE ICE BALL". 124 N20 RETINAL PRB STRAIGHT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12561048 ↗
  • MalfunctionJun 4, 2021Excess Flow or Over-Infusion; Leak/Splash; Mechanical Problem; Temperature Problem

    LEAKING HANDLE GETS ICE COLD. (B)(4) FOUND; HIGH FREZZE FLOW 16.5MM, POOR SEATING. 3. N20 RETINAL PRB STRAIGHT 124. E-COMPLAINT- (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 11941167 ↗

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