Valleylab E1502Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10884524000305), received between Oct 12, 2017 and Mar 18, 2024 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (23 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2024Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material

  ACCORDING TO THE REPORTER, DURING PROCEDURE, PATIENT WAS BURNT RELATIVE TO TWO OF THE SAME PART NUMBER ELECTRODES HAVING BEEN USED. ONE DEVICE HAD A BURN HOLE ON IT AND ANOTHER HAD ONE THAT WAS SMALLER IN VISUAL DETECTION.

  Patient problems: Burn(s)

  MAUDE report 18927514 ↗
• MalfunctionMar 18, 2024Adverse Event Without Identified Device or Use Problem; Scratched Material; Adverse Event Without Identified Device or Use Problem; Scratched Material

  ACCORDING TO THE REPORTER, DURING PROCEDURE, PATIENT WAS BURNT RELATIVE TO TWO OF THE SAME PART NUMBER ELECTRODES HAVING BEEN USED. ONE DEVICE HAD A BURN HOLE ON IT AND ANOTHER HAD ONE THAT WAS SMALLER IN VISUAL DETECTION.

  Patient problems: Burn(s)

  MAUDE report 18927513 ↗
• MalfunctionSep 25, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE REALIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808052 ↗
• MalfunctionSep 15, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE REALIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761042 ↗
• MalfunctionSep 15, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE RILIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761033 ↗
• MalfunctionSep 15, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STERILIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761027 ↗
• MalfunctionSep 15, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STERILIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17761007 ↗
• MalfunctionSep 14, 2023Peeled/Delaminated; Contamination /Decontamination Problem; Peeled/Delaminated; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE RILIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749441 ↗
• MalfunctionSep 14, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE REALIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749063 ↗
• MalfunctionSep 14, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE RILIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745973 ↗
• MalfunctionAug 25, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SAME CLIENT HAS OBSERVED THAT THE INSULATION WAS ALSO BEING CRACKED AFTER THE FIRST STE RILIZATION. THE DEVICE WAS NOT USED AS THE CRACKS WERE VISIBLE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17626777 ↗
• MalfunctionJul 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING GYNECOLOGICAL SURGERY, PATIENT WAS OPERATED ON FOR THE FOLLOWING PROCEDURE "CONIZATION OF THE UTERINE CERVIX". SKIN BURN (BURN ON LEFT VULVAR LIP) DUE TO THERMAL DIFFUSION, USE OF ELECTRIC SCALPEL EXTENSION DURING CONIZATION PROBABLY DEFECTIVE. NO CONTACT BETWEEN THE TIP OF THE INSTRUMENT AND THE PATIENT'S SKIN. NO SPECIFIC ACTIONS. THE DEVICE CAUSED A BURN DUE TO A BREAK IN THE PROTECTIVE SHEATH. STERILIZATION ENSURES THAT THE SHEATH WAS VISUALLY VERIFIED PRIOR TO AUTOCLAVING. THE DEGREE OF BURN NOT KNOWN.

  Patient problems: Burn(s)

  MAUDE report 17316529 ↗
• MalfunctionMay 12, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING BREAST AUGMENTATION AND MASTOPEXY, THE INSULATION HAD CRACKS AND THE PATIENT HAD A 2CM SECOND DEGREE BURN AT THE BREAST LINE. THE PATIENT WAS NOW FINE HOWEVER, IT HAD TO HAD THE BURN SURGICALLY RESECTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16920605 ↗
• MalfunctionMay 12, 2023Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING BREAST AUGMENTATION AND MASTOPEXY, THE INSULATION HAD CRACKS AND THE PATIENT HAD A 2CM SECOND DEGREE BURN AT THE BREAST LINE. THE PATIENT WAS NOW FINE HOWEVER, IT HAD TO HAD THE BURN SURGICALLY RESECTED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16920483 ↗
• MalfunctionFeb 6, 2023Break; Peeled/Delaminated; Device Damaged Prior to Use; Scratched Material; Break; Peeled/Delaminated; Device Damaged Prior to Use; Scratched Material

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE'S INSULATION WAS CHIPPED ON ONE PART. THE DEVICE WAS ALSO SCRATCHED AND HAD DENTS. THE CRACK WAS PROBABLY THERE AFTER THE STERILIZATION, BUT THE NURSE NOTICED THAT ON SURGERY. AFTER NOTICING THE ISSUE, THE DEVICE WAS REPLACED. NOTHING FELL ON PATIENT'S CAVITY AND THERE WAS NO MEDICAL INTERVENTION DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16308574 ↗
• MalfunctionJan 4, 2023Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LOOP OR LARGE LOOP EXCISION OF THE TRANSFORMATION ZONE (LLETZ) CONIZATION, THE PATIENT SUSTAINED A BURN FROM THE DEVICE BY ENERGY LEAKAGE ON A HEALTHY TISSUE AT THE VAGINAL WALL. THE DEGREE OF BURN WAS UNKNOWN. THERE WAS NO TREATMENT DONE; INSTEAD IT WAS ALLOWED FOR NATURAL HEALING.

  Patient problems: Burn(s)

  MAUDE report 16096465 ↗
• MalfunctionDec 29, 2022Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A MAMMA AUGMENTATION, THE STRAIGHT ELECTRODE WAS DIFFERENT FROM THE PREVIOUS STRAIGHT ELECTRODE THEY BOUGHT OVER THE PAST 10 YEARS, THE NEW ELECTRODE LACKED INSULATION AND CAUSED LITTLE BURNINGS ON THE SKIN OF THE PATIENT DUE TO THE SPARKING/ARCING OF THE ELECTRODE, THE CUSTOMER ALSO STATED THAT THE NEW ELECTRODE HAVE A COLORING IN THE SAME BLUE PATTERN, WHEREAS THE ¿OLD ELECTRODES¿ HAVE TWO DIFFERENT BLUE COLORINGS (ON THE SHAFT DARKER THE REST NORMAL BLUE), TWO ELECTRODES WERE USED WITHIN THE PROCEDURE WHILE THE REST ARE BACK-TO-STOCK. THE BURN SITE WAS TREATED WITH NORMAL SKIN LOTION.

  Patient problems: Burn(s)

  MAUDE report 16074073 ↗
• MalfunctionDec 29, 2022Arcing; Adverse Event Without Identified Device or Use Problem; Arcing; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A MAMMA AUGMENTATION, THE STRAIGHT ELECTRODE WAS DIFFERENT FROM THE PREVIOUS STRAIGHT ELECTRODE THEY BOUGHT OVER THE PAST 10 YEARS, THE NEW ELECTRODE LACKED INSULATION AND CAUSED LITTLE BURNINGS ON THE SKIN OF THE PATIENT DUE TO THE SPARKING/ARCING OF THE ELECTRODE, THE CUSTOMER ALSO STATED THAT THE NEW ELECTRODE HAVE A COLORING IN THE SAME BLUE PATTERN, WHEREAS THE ¿OLD ELECTRODES¿ HAVE TWO DIFFERENT BLUE COLORINGS (ON THE SHAFT DARKER THE REST NORMAL BLUE), TWO ELECTRODES WERE USED WITHIN THE PROCEDURE WHILE THE REST ARE BACK-TO-STOCK. THE BURN SITE WAS TREATED WITH NORMAL SKIN LOTION.

  Patient problems: Burn(s)

  MAUDE report 16073702 ↗
• InjuryDec 26, 2022Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, FIVE ELECTRODES HAD PARTIALLY BROKEN INSULATION, SMALL CRACKS AND DENTS. THE INSULATION OF AN ELECTROCAUTERY EXTENSION TURNED OUT TO BE LEAKING, WHICH LED TO A SMALL-AREA CONTACT BURN IN THE AREA OF THE RIGHT BREAST IN A PATIENT. THERE COULD POTENTIALLY BE A WOUND HEALING DISORDER ON THE BREAST. IN THE WORST CASE IT COULD BREAST IMPLANT EXPOSED, WHICH WOULD RESULT IN AT LEAST TWO REVISION SURGERIES. MOSTLY MIXED SUPERFICIAL AND DEEP PARTIAL THICKNESS BURNS (SECOND DEGREE) WITH VERY SMALL AREAS OF THIRD DEGREE INJURIES. TREATMENT DONE WAS CONSERVATIVE TREATMENT.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 16046717 ↗
• InjuryDec 21, 2022Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, FIVE ELECTRODES HAD PARTIALLY BROKEN INSULATION, SMALL CRACKS AND DENTS. THE INSULATION OF AN ELECTROCAUTERY EXTENSION TURNED OUT TO BE LEAKING, WHICH LED TO A SMALL-AREA CONTACT BURN IN THE AREA OF THE RIGHT BREAST IN A PATIENT. THERE COULD POTENTIALLY BE A WOUND HEALING DISORDER ON THE BREAST. IN THE WORST CASE IT COULD BREAST IMPLANT EXPOSED, WHICH WOULD RESULT IN AT LEAST TWO REVISION SURGERIES.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 16028552 ↗
• InjuryDec 21, 2022Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, 5 ELECTRODES HAD PARTIALLY BROKEN INSULATION, SMALL CRACKS AND DENTS. THE INSULATION OF AN ELECTROCAUTERY EXTENSION TURNED OUT TO BE LEAKING, WHICH LED TO A SMALL-AREA CONTACT BURN IN THE AREA OF THE RIGHT BREAST IN A PATIENT. THERE COULD POTENTIALLY BE A WOUND HEALING DISORDER ON THE BREAST. IN THE WORST CASE IT COULD BREAST IMPLANT EXPOSED, WHICH WOULD RESULT IN AT LEAST 2 REVISION SURGERIES. MOSTLY MIXED SUPERFICIAL AND DEEP PARTIAL THICKNESS BURNS (2ND DEGREE) WITH VERY SMALL AREAS OF 3RD DEGREE INJURIES. TREATMENT DONE WAS CONSERVATIVE TREATMENT.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 16028402 ↗
• InjuryDec 21, 2022Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, FIVE ELECTRODES HAD PARTIALLY BROKEN INSULATION, SMALL CRACKS AND DENTS. THE INSULATION OF AN ELECTROCAUTERY EXTENSION TURNED OUT TO BE LEAKING, WHICH LED TO A SMALL-AREA CONTACT BURN IN THE AREA OF THE RIGHT BREAST IN A PATIENT. THERE COULD POTENTIALLY BE A WOUND HEALING DISORDER ON THE BREAST. IN THE WORST CASE IT COULD BREAST IMPLANT EXPOSED, WHICH WOULD RESULT IN AT LEAST TWO REVISION SURGERIES. MOSTLY MIXED SUPERFICIAL AND DEEP PARTIAL THICKNESS BURNS (SECOND DEGREE) WITH VERY SMALL AREAS OF THIRD DEGREE INJURIES. TREATMENT DONE WAS CONSERVATIVE TREATMENT.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 16026420 ↗
• InjuryDec 21, 2022Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem; Peeled/Delaminated; Electrical Shorting; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, FIVE ELECTRODES HAD PARTIALLY BROKEN INSULATION, SMALL CRACKS AND DENTS. THE INSULATION OF AN ELECTROCAUTERY EXTENSION TURNED OUT TO BE LEAKING, WHICH LED TO A SMALL-AREA CONTACT BURN IN THE AREA OF THE RIGHT BREAST IN A PATIENT. THERE COULD POTENTIALLY BE A WOUND HEALING DISORDER ON THE BREAST. IN THE WORST CASE IT COULD BREAST IMPLANT EXPOSED, WHICH WOULD RESULT IN AT LEAST TWO REVISION SURGERIES.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 16026386 ↗
• MalfunctionNov 17, 2022Peeled/Delaminated; Arcing; Peeled/Delaminated; Arcing

  ACCORDING TO THE REPORTER, DURING LIVER RESECTION, WHEN PROCESSING LIGAMENT AROUND LIVER, A SPARK OCCURRED ON THE EXTENSION AXIS ITSELF, AND THERE WERE TRACES OF ABLATION ALONG THE LONG AXIS FOR SEVERAL CENTIMETERS ON THE EXTENSION AXIS. THERE WAS SOMETHING LIKE A BLACK CHARRED LINE THAT SEEMED TO HAVE FORMED WHEN IT CAME INTO CONTACT WITH THE EXTENSION SHAFT. IT WAS REPLACED TO ANOTHER EXTENSION SHAFT AND USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815419 ↗
• MalfunctionOct 24, 2022Peeled/Delaminated; Scratched Material; Peeled/Delaminated; Scratched Material

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHEN THE DEFECTIVE EXTENSION SHAFT WAS USED IN THE OP, IT SEEMS THAT THE PHYSICIAN CON FIRMED THAT THERE WAS A SCRATCH MARK ON THE SIDE. THERE WAS NO PATIENT INJURY. MEDTRONIC INITIAL INVESTIGATION FOUND THAT VISUAL INSPECTION FOUND SCRATCHES AND CRACKS TO THE INSULATION AND TROUBLESHOOTING CAN CONFIRM THE INSULATION DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660829 ↗