Valleylab E2515NSBRecalls & reported problems
Covidien LP · Rocker Switch Pencil; Caution: For manufacturing, processing, or repacking. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884524003603), received between Aug 10, 2021 and Aug 10, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Remains Activated” (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
- Device Remains Activated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2021Device Remains Activated; Device Remains Activated
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN USING THE DIATHERMY PEN, THE BUTTON WAS PRESSED BUT STAYED PRESSED SO IT COULD NO LONGER BE USED AFTER. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12305295 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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