3M™ 9165Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 50707387462593), received between Jan 31, 2018 and Aug 20, 2020 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 25, 2022Open, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1608-2022 · Root cause: Environmental control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED A (B)(6)-YEAR-OLD FEMALE PATIENT, WEIGHING (B)(6) LBS WAS UNDERGOING A BREAST AUGMENTATION ON (B)(6) 2020 AND ALLEGED A 3RD DEGREE FULL THICKNESS BURN FROM 3M¿ UNIVERSAL ELECTROSURGICAL PAD 9165. THE PATIENT WAS POSITIONED SUPINE FOR A ONE-HOUR SURGERY AND GROUNDED ON THE LEFT THIGH. THE BURN WAS REPORTED TO BE 9 X 2.5 CM. FORCE FX¿ ELECTROSURGICAL GENERATOR CUT AND COAGULATION SETTINGS WERE 50; TOTAL ACTIVATION TIME OF THE ACTIVE ELECTRODE IS UNKNOWN. THERE WAS NO ALARM DURING THE SURGERY. UPON REMOVAL; THE PLATE WAS COMPLETELY ADHERED TO THE PATIENT AND THERE WAS NO DIFFICULTY NOTED ON REMOVAL. MEDICAL HISTORY INCLUDES NO KNOWN ALLERGIES OR SKIN SENSITIVITIES. APPROXIMATELY TWO WEEKS AFTER INJURY THE SURGEON PERFORMED A DIRECT EXCISION OF THE BURN. CURRENTLY PATIENT IS HEALING FROM THE EXCISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 10431974 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE ALLEGED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT, WEIGHING (B)(6) KG, UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE ON (B)(6) 2019. THE SURGERY WAS 5 HOURS IN LENGTH. THE PATIENT WAS IN A HORIZONTAL DORSAL DECUBITUS POSITION DURING THE PROCEDURE. THE PATIENT HAD A 3M ELECTROSURGICAL PLATE (MODEL 9165) PLACED ON THE LEFT INTERSCAPULAR REGION. NO SKIN PREPARATION WAS PERFORMED. AN INSITE C3 NAVX RF GENERATOR WAS USED. DURING THE REMOVAL OF THE SCALPEL PLATE, IN THE DORSAL THORACIC REGION BETWEEN THE LEFT SCAPULA AND THE SPINE, A SKIN LESION WAS NOTED. THE INJURY WAS DESCRIBED AS A SKIN CAUTERIZATION/BURN. NO PATIENT SKIN SENSITIVES/ALLERGIES WERE SPECIFIED. THE WOUND WAS REPORTEDLY LOCATED UNDER THE PLATE'S EDGE REGION. THE PLATE WAS REMOVED WITHOUT DIFFICULTY. THE PLATE WAS REPORTEDLY FULLY ADHERED WHEN REMOVED. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PATIENT'S FAMILY IS REPORTEDLY TAKING THE PATIENT TO THE HOSPITAL'S OUTPATIENT CLINIC TO HAVE A STOMA THERAPIST NURSE BANDAGE THE WOUND DAILY. PAPAIN IS BEING USED FOR TREATMENT. THE NURSE REPORTED THE PATIENT WAS DOING WELL AND THE WOUND WAS NOT REGRESSING.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8966900 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE ALLEGED THAT A (B)(6) FEMALE PATIENT, WEIGHING (B)(6), UNDERWENT A RADIOFREQUENCY CARDIAC ABLATION PROCEDURE ON (B)(6) 2019. THE SURGERY WAS 2 HOURS IN LENGTH. THE PATIENT WAS IN A HORIZONTAL DORSAL DECUBITUS POSITION DURING THE PROCEDURE. THE PATIENT HAD A 3M ELECTROSURGICAL PLATE (MODEL 9165) PLACED ON THE LEFT INTERSCAPULAR REGION. NO SKIN PREPARATION WAS PERFORMED. AN INSITE C3 NAVX RF GENERATOR WAS USED. DURING THE REMOVAL OF THE SCALPEL PLATE, IN THE DORSAL THORACIC REGION BETWEEN THE LEFT SCAPULA AND THE SPINE, A SKIN LESION WAS NOTED. THE INJURY WAS DESCRIBED AS SKIN CAUTERIZATION/BURN. NO PATIENT SKIN SENSITIVES/ALLERGIES WERE SPECIFIED. THE WOUND WAS REPORTEDLY LOCATED UNDER THE PLATE'S EDGE REGION. THE PLATE WAS REMOVED WITHOUT DIFFICULTY. THE PLATE WAS REPORTEDLY FULLY ADHERED WHEN REMOVED. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE WOUND WAS REPORTEDLY TREATED DAILY, AT HOME BY THE PATIENT'S FAMILY, USING PAPAIN DRESSINGS. THE NURSE REPORTED THE PATIENT WAS DOING WELL WITH THE CLINICAL TREATMENT AT HOME.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8965329 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR-OLD HISPANIC FEMALE PATIENT, WEIGHING (B)(6) KGS, REPORTEDLY HAD TWO 9165 3M¿ UNIVERSAL ELECTROSURGICAL PLATES APPLIED PRIOR TO AN OPEN REDUCTION PROCEDURE OF THE PROXIMAL HUMERAL ON (B)(6) 2019. NO SKIN PREPARATION WAS CONDUCTED PRIOR TO APPLICATION. THE SURGERY WAS APPROXIMATELY 2 HOURS IN LENGTH. THE PATIENT WAS INITIALLY IN A SUPINE POSITION AND THEN REPOSITIONED TO A SEMI-FOWLER POSITION DURING THE SURGERY. AT THE END OF THE PROCEDURE, EACH PLATE WAS REPORTEDLY FULLY ADHERED AND REMOVED SLOWLY. THE PATIENT WAS NOTED IN HER ROOM, POST-OP, AS HAVING ERYTHEMA AND A SECOND DEGREE BURN, APPROXIMATELY 50CM IN SIZE, WITH BLISTERS. THE INJURY WAS REPORTEDLY LOCATED IN THE DORSAL, LEFT LUMBAR REGION AND LEFT GLUTEUS. THE INJURIES WERE REPORTED TO NOT BE UNDER THE PLATES. THE PATIENT HAD NO HISTORY OF SKIN SENSITIVITIES. THE PATIENT WAS TREATED BY A PHYSICIAN AND UNDERWENT BURN WOUND HEALING AND AMBULATORY CARE EVERY 48 HOURS. THE PATIENT'S CURRENT CONDITION WAS REPORTED AS STABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8873967 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE IN (B)(6) REPORTED A 9165 3M¿ UNIVERSAL ELECTROSURGICAL PATIENT PLATE WAS APPLIED TO A PATIENT'S RIGHT CALF DURING A PERICARDIAL WINDOW PROCEDURE. THE PATIENT ALLEGEDLY EXPERIENCED A BURN ON THE RIGHT CALF, SLIGHTLY LARGER THAN A FIFTY-CENT COIN. SKIN WAS REPORTEDLY PEELED FROM THE BURN AREA WHEN THE PATIENT PLATE WAS REMOVED. FUCIDIN CREAM WAS REPORTEDLY USED FOR TREATMENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7890619 ↗
• MalfunctionAug 10, 2018Material Separation

  3M UNIVERSAL ELECTROSURGICAL PAD: SPLIT WITH CORD USED WITH ANOTHER DEVICE MALFUNCTIONED. THIS PRODUCT IS NOT SUPPLIED BY THE MANUFACTURER OF THE MACHINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7771827 ↗
• MalfunctionMay 22, 2018Detachment Of Device Component; Device Displays Incorrect Message

  PATIENT BROUGHT TO THE OR FOR A LAPAROSCOPIC SLEEVE GASTRECTOMY WITH DR. AFTER INTUBATION AND POSITIONING, GROUNDING PAD WAS APPLIED TO THE PATIENT'S LATERAL THIGH AND PLUGGED INTO CAUTERY MACHINE. CAUTERY MACHINE BEGAN ALARMING THAT CAUTERY PAD WAS NOT ATTACHED, ALTHOUGH PAD WAS STILL ATTACHED TO PATIENT. PAD WAS UNPLUGGED AND PLUGGED BACK IN AND CONTINUED TO REGISTER AND UNREGISTER THE GROUNDING PAD BEING ATTACHED TO THE PATIENT. GROUNDING PAD WAS REMOVED AND PLACED IN THE PACKAGING IT CAME IN, AND A NEW, FUNCTIONING PAD WAS PLACED. NO PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7533803 ↗
• MalfunctionFeb 16, 2018Failure to Sense; Device-Device Incompatibility

  PATIENT WAS BROUGHT TO OPERATING ROOM FOR A RIGHT TOTAL KNEE REPLACEMENT WITH DR. THE GROUNDING PAD WAS APPLIED TO THE PATIENT'S ABDOMEN PROPERLY AND PLUGGED INTO THE CAUTERY MACHINE, WHICH WOULD NOT RECOGNIZE THAT GROUNDING PAD WAS PLUGGED IN. AFTER CHECKING THE PLACEMENT OF THE PAD AND RE-PLUGGING THE CORD IN, A NEW GROUNDING PAD WAS PLACED IN THE SAME SPOT AND WORKED PROPERLY. SURGERY WAS DELAYED AS CAUTERY COULDN'T BE USED UNTIL ISSUE WAS FIXED. MALFUNCTIONING GROUNDING PAD AND WRAPPER WERE BROUGHT TO FRONT DESK FOR RN.

  Patient problems: No Information

  MAUDE report 7276918 ↗
• InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL EMPLOYEE REPORTED THAT A PATIENT EXPERIENCED A SECOND DEGREE BURN (SIZE; 4% OF FOREARM) AND BLISTERING ON HER RIGHT FOREARM DURING A FOUR HOUR UNSPECIFIED TYPE OF DEBRIDEMENT SURGERY. A 3M UNIVERSAL ELECTROSURGICAL PAD WAS ALLEGEDLY APPLIED TO HER RIGHT UPPER ARM. THE BURN AND BLISTERING DID NOT OCCUR UNDER THE ELECTROSURGICAL PAD PLACEMENT. THE PATIENT ALLEGEDLY REQUIRED SURGICAL DEBRIDEMENT, MINOR TENDON LIBATION AND A FASCIOTOMY FOR TREATMENT AND WAS REPORTEDLY IN GOOD CONDITION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7231665 ↗