LigaSure LF1212A (UDI 20884521186030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521186030), received between Nov 30, 2017 and Oct 26, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2021Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING ENLARGED TOTAL THYROIDECTOMY, THE DEVICE HAD PARTIAL SEAL. REGRASP ALERT WAS OBSERVED AND AN END TONE WAS HEARD. THERE WAS NO EVIDENCE OF ENERGY DELIVERY. THE DOCTOR USED TWO LIGASURE DEVICES, AS THE FIRST ONE WAS IN THE HEAD KIT AND NECK FAILURE. THE DEVICE WOULD NOT WORK CORRECTLY, THE FUNCTIONS WAS INTERMITTENT. THE SECOND DEVICE WORKED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12695088 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED HYSTERECTOMIES PERFORMED WITH TRADITIONAL CUTTING AND TYING TOOLS AND TH OSE PERFORMED WITH LIGASURE INSTRUMENTS IN PATIENTS WITH KNOWN WITH PLACENTAL INSERTION ANOMALIES BETWEEN 2013 AND 2019. THERE WERE 28 PATIENTS IN THE LIGASURE GROUP AND POST-OPERATIVE COMPLICATIONS INCLUDED: TRANSFUSIONS, BLADDER REPAIR AND POST-OPERATIVE INFECTION. INTERVENTIONS FOR BLADDER REPAIR AND INFECTION NOT LISTED.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11249965 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE SURGEON USED THE DEVICE FOR A SALPINGO-OOPHORECTOMY ON A PATIENT WHO WAS POST-OPERATIVE C-SECTION. THE PATIENT HAD TO BE BROUGHT BACK TO THE OPERATING ROOM(OR) FOR RE-OPERATION DUE TO POST-OPERATIVE BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 8065315 ↗
• MalfunctionNov 30, 2017Energy Output To Patient Tissue Incorrect; Device Stops Intermittently; Device Displays Incorrect Message; Energy Output To Patient Tissue Incorrect; Device Stops Intermittently; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE THE DEVICE WAS PRODUCING PARTIAL SEALS WITH NO RE-GRASP ALERTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7072055 ↗