Valleylab E1562Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884524000183), received between Mar 24, 2017 and Jul 29, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Blood Loss1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LOOP ELECTRICAL EXCISION PROCEDURE, THE WIRE SEPARATED FROM ONE END OF THE ELECTRODE. A NEW DEVICE WITH THE SAME MODEL WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641312 ↗MalfunctionDec 8, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S TUNGSTEN BUCKLE BROKE DURING USE ON A PATIENT. THE ENTIRE LOOP WAS DETACHED ON ONE SIDE. THE PATIENT HAS NOT UNDERGONE ANY ADDITIONAL SURGERY OR CONTROL RADIOGRAPHY. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10969526 ↗InjuryMar 24, 2017Break; Break
THE CUSTOMER REPORTED THAT THE LOOP ELECTRODE SNAPPED AT EDGE DURING A LEEP PROCEDURE. A FORCEFXC GENERATOR WITH COAG OUTPUT AT 70. THERE WAS A FAIR AMOUNT OF TISSUE LOSS. ADDITIONALLY, THERE WAS MORE THAN 500 CC OF BLEEDING BUT NO TRANSFUSION WAS NEEDED. THE AREA WAS SUTURED. THE PATIENT IS STABLE.
Patient problems: Blood Loss
MAUDE report 6433383 ↗
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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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