Valleylab E2516GNSBRecalls & reported problems
Covidien LP · Button 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 10884524002989), received between Feb 4, 2019 and Feb 4, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fire” (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
- Fire1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2019Fire; Fire
ACCORDING TO THE REPORTER, DURING PROCEDURE, PENCIL CAUGHT ON FIRE LIKE A CANDLE FLAME AS RESIDENT WAS HOLDING IT RIGHT AFTER USING IT ON A PATIENT. THE FLAME WAS EXTINGUISHED AND REMOVED FROM THE FIELD. REPLACED IT WITH NEW SIMILAR DEVICE AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8300968 ↗
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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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