3M™ 9160FRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10707387462618), received between Feb 8, 2018 and Mar 15, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A CHILD ALLEGEDLY EXPERIENCED 1ST AND 2ND DEGREE BURNS WITH BLISTERING ON THE INNER ASPECT OF THE LEFT CALF AND HYPEREMIA ON THE RIGHT CALF WITH THE USE OF THE 3M¿ UNIVERSAL ELECTROSURGICAL PADS 9160F, LOT 202404EP. SILVER SULFADIAZINE AND GAUZE WERE APPLIED. THE PATIENT HAD REPORTEDLY UNDERWENT AN EMERGENCY APPENDECTOMY WITH THE USE OF AN ELECTRIC SCALPEL.

  Patient problems: Burn(s)

  MAUDE report 16547687 ↗
• InjuryNov 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT ALLEGEDLY EXPERIENCED A SUPERFICIAL WITH A 2ND DEGREE LEFT THIGH BURN DURING USE OF 3M¿ UNIVERSAL ELECTROSURGICAL PADS 9160F, LOT 2025-04 EU. NO MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 15798479 ↗
• InjuryOct 19, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A MALE PEDIATRIC PATIENT EXPERIENCED AN 8CM X 2CM TRANSVERSE LESION ON THAT ANTERIOR ASPECT OF THE LEFT THIGH WITH THE USE OF 3M¿ UNIVERSAL ELECTROSURGICAL PADS 9160F, LOT 20250ER. A SECOND-DEGREE BURN, NECROTIC TISSUE, SMALL BLISTERS, ERYTHEMA, ITCHING/BURNING SENSATION AND SIGNS OF RETRACTION WITH A SMALL HALO OF HYPEREMIA WERE OBSERVED. AFTER TWO DAYS, THE BURN WAS RE-ASSESSED AND WAS SUBSEQUENTLY DEEMED A POST OPERATIVE 9CM X 2.5CM THIRD-DEGREE BURN WITH RUPTURED BLISTERS AND DEVITALIZED TISSUE ALLEGEDLY CAUSED BY THE 3M¿ UNIVERSAL ELECTROSURGICAL PADS 9160F. THE WOUND WAS REPORTEDLY DRIER WITH LITTLE EXUDATE AND NO PHLOGISTIC SIGNS WERE OBSERVED. A NURSE REPORTED THAT MEDICAL TREATMENT WAS NECESSARY. THE WOUND WAS CLEANED WITH SALINE SOLUTION, WITHOUT SHARP DEBRIDEMENT, AND SILVER SULFADIAZINE WITH DUODERM® CGF¿ DRESSING® WAS APPLIED FOR AUTOLYTIC DEBRIDEMENT. SUBSEQUENT REASSESSMENT REPORTED CLEANED DEAD SKIN (BLEEDING) AND DUODERM® CGF¿ DRESSING® WAS APPLIED TO KEEP NECROSIS ADHERED TO THE WOUND BED. THE NEXT DRESSING CHANGE SCHEDULE WAS EXTENDED ONE DAY TO REPORTEDLY PROMOTE AUTOLYTIC DEBRIDEMENT. NO PERMANENT INJURY WAS REPORTEDLY CONFIRMED. THE PATIENT IS REPORTEDLY DOING

  Patient problems: Burn(s)

  MAUDE report 15633835 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE IN (B)(6) ALLEGED THAT A (B)(6)-YEAR-OLD MALE PATIENT, WEIGHING (B)(6) KG, UNDERWENT A RESECTION OF BILATERAL NASAL SYNECHIA PROCEDURE ON (B)(6) 2019. THE SURGERY WAS 40 MINUTES IN LENGTH. THE PATIENT WAS IN A SUPINE POSITION DURING THE PROCEDURE. THE PATIENT HAD A 3M¿ ELECTROSURGICAL PLATE (MODEL 9160F) PLACED ON THE ANTERIOR PORTION OF HIS LEFT LOWER THIGH. THE PLATE WAS REPORTEDLY APPLIED FAR FROM THE SURGERY SITE OVER A METAL IMPLANT. NO SKIN PREPARATION WAS PERFORMED. DENSE BODY HAIR WAS REPORTED TO BE PRESENT AT THE PLATE SITE. THE PHYSICIAN REPORTEDLY REQUESTED AN INCREASE OF 2X THE SCALPEL POWER. A BP 150 - IMA GENERATOR WAS USED. AN ALARM REPORTEDLY SOUNDED DURING THE PROCEDURE. THE EMPLOYEE ALLEGED A DARKENED SKIN LESION WITH REDDENED EDGES WAS OBSERVED ON THE PATIENT'S LEFT THIGH INTRA-OP. THE INJURY WAS APPROXIMATELY 2 CM IN SIZE AND DESCRIBED AS SKIN CAUTERIZATION/ 2ND DEGREE BURN. THE WOUND WAS REPORTEDLY LOCATED UNDER THE PLATE. NO PATIENT SKIN SENSITIVES/ALLERGIES WERE SPECIFIED. THE PLATE WAS REPORTEDLY REMOVED, WITHOUT DIFFICULTY, FROM THE TOP TO BOTTOM BY THE CABLE FIXING TAB. THE EMPLOYEE REPORTED THE PLATE WAS NOT ADHERED WELL WHEN REMOVED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9082087 ↗
• InjuryFeb 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE ALLEGED A PATIENT EXPERIENCED A "WOUND" WHEN A 9160F 3M¿ UNIVERSAL ELECTROSURGICAL PAD WAS REMOVED FROM THE RIGHT THIGH. THE HOSPITAL EMPLOYEE ALLEGED THE PATIENT'S SKIN REMAINED STUCK TO THE PAD WHEN IT WAS REMOVED.

  Patient problems: Injury

  MAUDE report 8327192 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE ALLEGED THAT A 9160F 3M UNIVERSAL ELECTROSURGICAL PAD WAS APPLIED TO AN UNSPECIFIED AREA ON A PATIENT. THE EMPLOYEE ALLEGED THE PATIENT EXPERIENCED A "BURN" AT FOUR CORNER ANGLED EDGES WHERE THE PAD HAD BEEN APPLIED. MEDICAL TREATMENT WAS NOT SPECIFIED.

  Patient problems: Burn(s)

  MAUDE report 7253033 ↗