Medline ESPB3000Recalls & reported problems
Medline Industries, Inc. · PENCIL,CAUTERY,PUSHBUTTON,STERILE,LF,SS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10080196775934), received between Aug 10, 2018 and Sep 29, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Arcing” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Arcing1
- Break1
- Electrical /Electronic Property Problem1
- Fire1
- Loose or Intermittent Connection1
- Smoking1
- Sparking1
Patient problems
- Burn(s)2
- No Clinical Signs, Symptoms or Conditions2
- Burning Sensation1
- Insufficient Information1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Skin Burning Sensation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Loose or Intermittent Connection; Arcing
Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 50936292 ↗MalfunctionSep 22, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849428 ↗MalfunctionSep 18, 2026Thermal Decomposition of Device
It was reported that "we have had yet another burn in the OR on 10/9/2023. This was a surgeon burn. No patient harm."
Patient problems: Skin Burning Sensation
MAUDE report 50818341 ↗MalfunctionAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that product caused burn in the OR.
Patient problems: Burning Sensation
MAUDE report 50495162 ↗MalfunctionAug 27, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Burn(s)
MAUDE report 50482438 ↗MalfunctionMay 22, 2026Break
IT WAS REPORTED THAT THE TIP IS COMING OFF THE PENCIL AND THEY HAVE HAD THIS HAPPENED A FEW TIMES WITH THIS SAME LOT #.
Patient problems: Insufficient Information
MAUDE report 25262789 ↗MalfunctionNov 16, 2018Smoking; Sparking
IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT AND BILOBECTOMY PROCEDURE THE CAUTERY PENCIL SPARKED AND SMOKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8078337 ↗MalfunctionAug 10, 2018Fire
IT WAS REPORTED THAT DURING A LAPAROTOMY WITH BILATERAL SALPINGOOOPHORECTOMY THE TIP OF THE CAUTERY DEVICE CAUGHT FIRE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7773338 ↗
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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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