Valleylab SM VSMP10Recalls & reported problems
Covidien LP · Smoke Management Pencil, Edge Coated Electrode, 10ft · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10884521836358), received between May 5, 2026 and May 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fire” (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
- Adverse Event Without Identified Device or Use Problem2
- Fire2
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.
MalfunctionMay 7, 2026Fire; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE PENCIL WAS SET DOWN ON THE DRAPE AFTER THE INITIAL PASS. THERE WAS A SMALL FLAME LIKE A LIGHTER FLAME PRESENT THAT BURNED HOLE THROUGH THE TOWEL AND DRAPE. IT WAS EXTINGUISHED BY STOPPING THE USE OF THE ELECTROCAUTERY. A SIMILAR DEVICE WAS USED AFTER THE FLAME WITH THE ORIGINAL GENERATOR AND THE SURGERY WAS COMPLETED WITH NO ISSUES.
Patient problems: Insufficient Information
MAUDE report 25116001 ↗MalfunctionMay 5, 2026Fire; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A LAMINECTOMY (L3), WITH BILATERAL FACETECTOMIES (L3-L4), BILATERAL FORAMINOTOMIES (L3), PART REMOVAL IF RETAINED SPINAL HARDWARE, POSTERIOR SEGMENTAL SPINAL INSTRUMENTATION (L3-L5), POSTEROLATERAL SPINAL FUSION (L3) TO THE CAUDAL FUSION MASS (L5), THE PENCIL WAS SET DOWN ON THE DRAPE AFTER THE INITIAL PASS. THERE WAS A SMALL FLAME LIKE A LIGHTER FLAME PRESENT THAT BURNED A HOLE THROUGH THE TOWEL AND DRAPE. IT EXTINGUISHED ITSELF; IT STOPPED AS QUICKLY AS IT STARTED. A SIMILAR DEVICE, FROM DIFFERENT MANUFACTURER WAS USED AFTER THE FLAME WITH THE ORIGINAL GENERATOR AND HAD NO ISSUES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25076375 ↗
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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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