Valleylab E1559Recalls & reported problems
Covidien LP · Tungsten Loop Electrode · Class 2
All models of Valleylab (97)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10884524000169), received between May 24, 2018 and Feb 12, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Connection Problem1
- Detachment of Device or Device Component1
Patient problems
- Burn(s)1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE LINE WAS BROKEN. THE DEVICE BROKE OFF AND THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11320689 ↗MalfunctionDec 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE DEVICE CAUSED A BURN ON A PATIENT.
Patient problems: Burn(s)
MAUDE report 9451897 ↗MalfunctionMay 24, 2018Break; Connection Problem; Break; Connection Problem
ACCORDING TO THE REPORTER, DURING CONIZATION, THE LOOP ELECTRODE BROKE AND WAS NOT RECOGNIZED BY THE GENERATOR. NOTHING FELL INTO PATIENT'S CAVITY. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7542676 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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