3M™ 9135-LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 50707387580730), received between Sep 1, 2017 and Nov 15, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Excessive Heating; Excessive Heating

  A PATIENT ALLEGEDLY EXPERIENCED A LEFT THIGH/HIP 3RD DEGREE BURN WITH THE USE OF THE 3M¿ UNIVERSAL ELECTROSURGICAL PADS, 9135-LP LOT 202503CO. THE PHYSICIAN OBSERVED A STRONG BURNING ODOR REPORTEDLY NOTED TO BE COMING FROM THE AREA OF THE GROUNDING PAD IN LESS THAN ONE MINUTE FROM THE START OF THE CASE, AND THE PHYSICIAN STOPPED THE CASE. THE PAD WAS NOTED TO HAVE A LARGE BURN MARK THROUGH IT AND ONTO THE PATIENT'S SKIN LEAVING A 3CM LONG X 1CM WIDTH LEFT THIGH/HIP THIRD DEGREE BURN WITH NECROTIC TISSUE THAT WAS ONLY PRESENT THROUGH THE BURNT AREA ON THE 3M PAD. THE GROUNDING PAD WAS REMOVED, AND A SECOND GROUNDING PAD WAS PLACED ON THE PATIENT ON THE OPPOSITE OF THE FIRST LOCATION AND THE CASE WAS CONTINUED. AN INTENSIVIST AND WOUND CENTER WERE CONSULTED, AND THE PATIENT WAS REFERRED TO THE EMERGENCY ROOM. THE PATIENT WAS SEEN THE NEXT DAY FOR WOUND CARE FOLLOW UP WITH SUBSEQUENT FOLLOW UPS. THE PATIENT IS CURRENTLY DOING "OKAY".

  Patient problems: Full thickness (Third Degree) Burn; Necrosis

  MAUDE report 18139802 ↗
• InjuryDec 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A HOSPITAL REPORTED A 64-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED BURNS WITH THE USE OF 3M¿ UNIVERSAL ELECTROSURGICAL PAD, 9135-LP. POST OPERATIVE JOINT REPLACEMENT SURGERY, THE FIRST RETURN ELECTRODE WAS REPORTEDLY CHARRED/BURNT AND THE PATIENT ALLEGEDLY EXPERIENCED 4TH DEGREE BURNS. MEDICAL INTERVENTION WAS REPORTEDLY REQUIRED, TYPE AND DATE ARE UNKNOWN AS WELL AS THE PATIENT'S CURRENT STATUS. ON 18-NOV-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO 3M: A STANDARD TYPE OF ELECTRODE WAS USED IN THIS CASE. THE RESISTANCE REPORTEDLY BECAME HIGH, AND THUS COULD NOT BE ENERGIZED. SCORCHING WAS OBSERVED ON THE OPPOSITE OF THE RETURN SAMPLE FROM THE CORD. IT WAS NOTED THAT THE CORD WAS PULLED, THE RETURN ELECTRODE PEELED OFF, THEREFORE, WAS IN CONTACT WITH THE SCORCHED AREA. IT WAS ASSESSED THAT THERE WAS NO PROBLEM WITH THE PRODUCT. THE GEL OF THE RETURNED SAMPLE WAS UNIFORM, AND ELECTRICITY COULD BE SUPPLIED AT FIRST. CONMED'S ELECTROSURGICAL UNIT CAN BE USED AS A SPLIT TYPE, THEREFORE, THIS CASE MAY NOT HAVE OCCURRED IF A SPLIT TYPE HAD BEEN USED. THIS CASE WAS REPORTEDLY DUE TO USER ERROR, ALTHOUGH THE RELATIONSHIP BETWEEN THE BURN AND THE 3M¿ UNIVERSAL ELECTROSURGICAL PADS 9135-LP CA

  Patient problems: Burn(s)

  MAUDE report 15958051 ↗
• InjuryJul 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A NURSE REPORTED A 9135-LP 3M¿ UNIVERSAL ELECTROSURGICAL PLATE WAS APPLIED TO A FEMALE PATIENT'S RIGHT ANTERIOR THIGH PRIOR TO BREAST REVISION SURGERY ON (B)(6) 2019. NO SKIN PREP WAS CONDUCTED AT THE PLATE SITE PRIOR TO APPLICATION. THE APPLICATION SITE WAS HAIR-FREE. SURGERY LENGTH WAS NOT SPECIFIED. THE PATIENT WAS PLACED IN A SUPINE POSITION DURING SURGERY. THE NURSE REPORTED ALL CONNECTIONS WERE CHECKED AND THE PAD CONNECTED WITH THE PATIENT'S SKIN. BRAND/ MODEL OF GENERATOR USED WAS NOT SPECIFIED. TOTAL ACTIVATION TIME OF THE ACTIVE ELECTRODE WAS NOT PROVIDED. THE ACTIVE ELECTRODE WAS USED INTERMITTENTLY FOR A MINIMAL TIME DURING EACH USE. THE NURSE REPORTED THE ELECTROSURGICAL PLATE WAS GENTLY REMOVED BY LOOSENING THE FAR CORNER OF THE PAD. THE PLATE WAS REPORTED TO BE INTACT AND ADHERED IN TOTAL TO THE PATIENT'S LEG UPON REMOVAL. A 3RD DEGREE BURN WOUND, 2X4 CENTIMETERS IN SIZE, WAS DISCOVERED ON THE PATIENT'S SKIN AT THE JUNCTION WHERE THE CORD ENTERS THE PAD. BURNS WERE ALSO NOTICED ON THE CORD. THE BURN WOUND WAS EXCISED AND A PRIMARY CLOSURE WAS COMPLETED. SILVADENE CREAM AND A TEGADERM DRESSING WAS APPLIED TO THE BURN SITE, UNSPECIFIED PAIN MEDICATION WAS PROVIDED, AND

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8776821 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A SURGEON REPORTED A 9135-LP 3M¿ UNIVERSAL ELECTROSURGICAL PAD WAS APPLIED TO A FEMALE PATIENT'S LEFT ANTERIOR LATERAL THIGH PRIOR TO A LIPO ABDOMINOPLASTY. FOLLOWING THE SURGERY, THE ELECTROSURGICAL PAD WAS REMOVED AND A FULL THICKNESS (3RD DEGREE) BURN WOUND WAS DISCOVERED ON THE PATIENT'S LOWER, LEFT LATERAL THIGH. THE BURN WOUND WAS EXCISED AND A PRIMARY CLOSURE WAS COMPLETED. THE PATIENT WAS HEALING WELL ONE WEEK FOLLOWING THE EVENT.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 7719511 ↗
• MalfunctionSep 1, 2017Component Missing; Component Missing

  IT WAS ALLEGED BY A USER FACILITY THAT A 3M UNIVERSAL ELECTROSURGICAL PAD WAS MISSING ITS CONDUCTIVE ADHESIVE. THE PRODUCT WITH MISSING CONDUCTIVE ADHESIVE WAS NOT USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6837750 ↗