DeRoyal 88-000722Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00749756157919), received between Aug 14, 2019 and Aug 9, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954154 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953355 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953314 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953306 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953166 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953151 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953138 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A DISTRIBUTING FACILITY REPORTED, "INSIDE PORTION OF THE PENCILS HAS PLACSTICK PIEC THAT RECEIVES ELECTROSURGICAL TIP AND THAT PLASTIC PIECE IS BREAKING.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19953137 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952997 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952974 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  A USER FACILITY REPORTED, "CAUTERY TIP CLIP IS BREAKING OFF INSIDE THE PENCIL. TIP IS NO LONGER SECURE AND IS EITHER SUCKED UP INSIDE THE PENCIL OR FALLS OUT INTO THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952962 ↗
• MalfunctionSep 13, 2019Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem; Self-Activation or Keying; Activation, Positioning or Separation Problem; Activation Problem

  THE ELECTROSURGICAL PENCIL WAS ACTIVATING WHILE NOT IN USE AND CAUSED A BURN APPROXIMATELY 2 CM TO THE PATIENT'S LEFT ANTERIOR THIGH.

  Patient problems: Burn(s); Injury

  MAUDE report 9047481 ↗
• MalfunctionSep 13, 2019Continuous Firing; Electrical /Electronic Property Problem; Continuous Firing; Electrical /Electronic Property Problem

  THE CAUTERY PENCIL REMAINED ACTIVE WITHOUT FINGER CONTROL ACTIVATING THE PENCIL. IT WAS SET ON THE PATIENT AND CAUSED A BURN TO THE PATIENTS BREAST. THE CAUTERY PENCIL DEFECT WAS REPLICATED AFTER THE EVENT IN THE OR BY THE SURGEON.

  Patient problems: Burn(s); Injury

  MAUDE report 9047097 ↗
• MalfunctionSep 13, 2019Continuous Firing; Electrical /Electronic Property Problem; Continuous Firing; Electrical /Electronic Property Problem

  THE COAGULATION BUTTON ON THE CAUTERY PENCIL REMAINED ACTIVATED EVEN THOUGH THE SURGEON WAS NOT PRESSING THE BUTTON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9046794 ↗
• MalfunctionAug 14, 2019Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off; Electrical /Electronic Property Problem; Device Remains Activated; Failure to Shut Off

  THE EXTENDEVAC PENCIL DID NOT SHUT OFF WHEN THE GENERATOR WAS TURNED OFF. THE PRODUCT WAS IN USE DURING A PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8894928 ↗