McKesson 22-ESP1HRecalls & reported problems
Mckesson Medical-Surgical Inc. · ELECTROSURGICAL PUSH BUTTON PENCIL PENCIL W/HOLSTER · 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 10612479209128), received between Mar 23, 2021 and May 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Sparking” (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
- Sparking1
Patient problems
- Superficial (First Degree) Burn2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Adverse Event Without Identified Device or Use Problem
THE CUSTOMER ALLEGED THAT WHILE USING A 22-ESP1H WITH AN UNKNOWN ELECTODE PART NUMBER/BRAND, THE PATIENT RECEIVED A MINOR BURN AROUND THE ENTRY WAY OF THE OPERATING SITE DURING A BREAST LIFT PROCEDURE.
Patient problems: Superficial (First Degree) Burn
MAUDE report 14461874 ↗MalfunctionMar 23, 2021Sparking
CUSTOMER ALLEGED THE PRODUCT "SPARKED AND LIT UP AND CAUSED SOME MINOR BURNS ON A PATIENT."
Patient problems: Superficial (First Degree) Burn
MAUDE report 11558086 ↗
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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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