Valleylab E2515HGNSBRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884524003634), received between May 24, 2018 and Sep 18, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fire” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2023Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING HIP PROCEDURE, THE DEVICE'S TEFLON TIP WAS LOSING COATING AND HAD DIFFERENT COLOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17766434 ↗
• MalfunctionDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CLIP BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. NONE FELL INTO THE PATIENT CAVITY. THE INCIDENT DID NOT CAUSE THE PROCEDURE TO EXTEND. THERE WAS NO OTHER MEDICAL INTERVENTION DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903836 ↗
• MalfunctionSep 27, 2022Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem; Inappropriate/Inadequate Shock/Stimulation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON FELT A SHOCK FROM HIS LEFT MIDDLE FINGER TIP UP TO HIS ELBOW AND GOT A BURN DUE TO THE CAUTERY PENCIL.

  Patient problems: Burn(s)

  MAUDE report 15490982 ↗
• MalfunctionFeb 24, 2022Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  ACCORDING TO THE REPORTER, DURING BREAST REDUCTION, THE PENCIL ACTIVATED WITHOUT THE SURGEON PRESSING THE BUTTON. IT WAS UNKNOWN IF THE FOOT PEDAL WAS ACTIVATED. ERROR CODES POPPED UP THAT STATED ACTIVATION SHOULD BE STOPPED. AFTER IT STOPPED, THE PENCIL WOULD NOT ACTIVATE WHEN SURGEON PRESSED THE ACTIVATION BUTTONS. THE ACCOUNT SAID THEY PLUGGED THE PENCIL INTO MONOPOLAR 2. SERIAL NUMBER OF THE FT10 USED WAS (B)(4). SAME PENCIL WAS PLUGGED INTO A SECOND FT10 AND IT STILL WOULD NOT ACTIVATE. A NEW PENCIL WAS OPENED FOR THE CASE AND IT WORKED WITHOUT ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590769 ↗
• MalfunctionOct 25, 2019Fire; Fire

  ACCORDING TO THE REPORTER, THE TIP OF THE DEVICE CAUGHT FIRE SIZE OF A BIRTHDAY CANDLE FLAME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241499 ↗
• MalfunctionAug 3, 2018Fire

  ACCORDING TO THE REPORTER, DURING USE, THE CAUTERY TIP IGNITED.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7747299 ↗
• InjuryJul 6, 2018Fire; Fire

  ACCORDING TO THE REPORTER, DURING A PLANNED CLOSURE OF MOHS DEFECT TO NASAL TIP AND UPPER CHEST WITH FULL THICKNESS SKIN GRAFT TO NOSE FROM RIGHT PRE-AURICULAR AREA AND PRIMARY CLOSURE OF THE UPPER MEDIAL CHECK DEFECT UNDER ANESTHESIA MONITORED INTRAVENOUS SEDATION. THEY INITIALLY RECEIVED THE PATIENT WITH OXYGEN VIA NASAL CANNULA, BUT WERE UNABLE TO MAINTAIN THE OXYGEN SATURATION ABOVE 90. THEY SWITCHED TO ORAL CAVITY AND A NON-REBREATHER MASK. THE HAIR AND BEARD WERE CLIPPED AND SKIN PREPPED WITH ANTISEPTIC SCRUB. ONE-HALF STRENGTH ANTISEPTIC PAINT WAS USED ON THE FACE AND FULL STRENGTH ANTISEPTIC PAINT WAS USED ON THE CHEST. MORE THAN THREE MINUTES LAPSED PRIOR TO DRAPING. PART OF DRAPE PLACED OVER BOTTOM PORTION OF THE NON-REBREATHER OXYGEN RESERVOIR OVER THE LEFT CHEST AND SHOULDER. BIPOLAR ELECTROCAUTERY WAS USED ON THE NASAL AREA AND THE RIGHT PRE-AURICULAR SKIN DONOR SITE AREA. WHEN ACTIVATING A MONOPOLAR ELECTROCAUTERY DEVICE WITH A NEEDLE TIP ON THE CHEST DEFECT, THERE WAS AN ARC AND FLASH OF FIRE. DRAPES WERE IMMEDIATELY REMOVED AND THE AREA WAS IMMEDIATELY FLUSHED WITH SALINE. THE ORAL AIRWAY WAS REMOVED AND INSPECTED AND A NASAL AIRWAY PLACED. THE PATIENT WAS INTUBATED

  Patient problems: Burn(s)

  MAUDE report 7667690 ↗
• MalfunctionMay 24, 2018Fire; Fire

  ACCORDING TO THE REPORTER, THE CAUTERY TIP CAUSED A FIRE IN THE OPERATING ROOM.

  Patient problems: No Information

  MAUDE report 7541633 ↗