Wallach 900629Recalls & reported problems
Coopersurgical, Inc. · LL100 Two-Trigger (with Thermocouple) Multi-Tip Cryosurgical System for N2O · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888937009866), received between Dec 9, 2020 and Apr 7, 2021 — classified as 3 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
- Excessive Cooling1
- Mechanical Problem1
- Physical Resistance/Sticking1
- Temperature Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2021Mechanical Problem; Defective Device; Temperature Problem
THE FOLLOWING MULTI TIP FREEZER OF THE 900629 APPEARS TO BE DEFECTIVE. THERE IS A FAULT IN THE FROST/DEFROST VALVE WHICH PREVENTS PROPER CIRCULATION. INCIDENT OCCURRED BEFORE PROCEDURE. DURING DEFROSTING, THE FREEZING POINT REMAINS BELOW 0 DEGREES DUE TO A MALFUNCTION IN THE FROST-DEFROST CIRCULATION. NO PROBLEMS WITH PATIENT. NO EXTRA ATTENTION WAS NEEDED. 1216677-2021-00063-1 LL100 MULTI TIP W TC 900629 (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11628669 ↗MalfunctionJan 11, 2021Excessive Cooling
REPORT SUBMITTED BY CSI SERVICE & REPAIR TEAM- "WOULD NOT DEFROST." REF (B)(4). LL100 MULTI TIP W-TC 900629 E-COMPLAINT: (B)(4).
Patient problems: Insufficient Information
MAUDE report 11148302 ↗MalfunctionDec 9, 2020Physical Resistance/Sticking
"FREEZE VALVE IS STUCK IN THE OPEN POSITION". 900629 LL100 MULTI TIP WTC E-COMPLAINT-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10980613 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.