3M™ 9165LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50707387523973), received between Sep 16, 2022 and Aug 30, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 78-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED AN ANTERIOR THIGH SECOND-DEGREE BURN WITH 13 CM LOCALIZED REDNESS, SWELLING, ITCHING SENSATION, MACERATION, PAIN, BLISTERING, AND PERMANENT DAMAGE FIVE HOURS POST APPLICATION OF 3M¿ UNIVERSAL ELECTROSURGICAL PADS, 9165 LOT 202509MD. THE PATIENT UNDERWENT A 5-HOUR HYSTERECTOMY PROCEDURE AND HAS NO KNOWN HISTORY OF SENSITIVITY OR ALLERGIC REACTION TO SKIN, MEDICATIONS, OR FOOD. THE SCALPEL WAS REPORTEDLY INSTALLED BY THE SURGEON, AND WAS UP TO DATE WITH PREVENTIVE MAINTENANCE, BIPOLAR MODE, WITH NO FINDINGS OF NONCONFORMITIES. THE HOSPITAL CONFIRMED NO ADDITIONAL INFORMATION OR PHOTOS WILL NOT BE PROVIDED.

  Patient problems: Blister; Erythema; Itching Sensation; Partial thickness (Second Degree) Burn; Skin Maceration; Swelling/ Edema

  MAUDE report 17653680 ↗
• InjurySep 16, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A HOSPITAL REPORTED A MALE 71-YEAR-OLD PATIENT EXPERIENCED A 12CM X 7CM SKIN TEAR ON THE LEFT CALF UPON REMOVING 3M¿ 9165 UNIVERSAL ELECTROSURGICAL PAD. AFTER A TEN-MINUTE POLYPECTOMY THE PAD WAS REMOVED, AND A SKIN TEAR WAS ALLEGED. SKIN WAS REMOVED FROM THE PAD AND APPLIED TO THE SKIN TEAR WITH USE OF STAPLES. SKIN WAS NOT PREPPED PRIOR TO APPLICATION AND REPORTED THERE WAS NO DIFFICULTY REMOVING THE PAD.

  Patient problems: Skin Tears

  MAUDE report 15439902 ↗