LigaSure LF2019Recalls & reported problems

Summary

The FDA's MAUDE database contains 948 adverse event reports that list this exact device (DI 10884521741096), received between Mar 28, 2018 and Sep 30, 2026 — classified as 73 injuries, 875 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (424 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 25 most recent of 948 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Energy Output Problem; Intermittent Energy Output

  It was reported that, during neck dissection on a thyroidectomy procedure, the device sealing can no longer be completed. There was no problem at the start of the procedure. Another device was used with the same generator and it worked fine. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949251 ↗
• MalfunctionSep 30, 2026Retraction Problem; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941440 ↗
• MalfunctionSep 29, 2026Energy Output Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50936632 ↗
• MalfunctionSep 28, 2026Energy Output Problem

  Patient problems: Insufficient Information

  MAUDE report 50922515 ↗
• MalfunctionSep 24, 2026Retraction Problem; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892407 ↗
• MalfunctionSep 22, 2026Retraction Problem; Difficult to Open or Close; Protective Measures Problem

  It was reported that, during a buccal mucosa cancer surgery, the Device Exact Dissector was connected to an generator when the knife blade could not retract and the jaw could not be opened shortly after the surgery began. It was not stuck on tissue. It was used on radial vein and cleaned after each use. The knife blade protruded beyond the edge of the jaws. Another device was used successfully with the same generator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856464 ↗
• MalfunctionSep 17, 2026Energy Output Problem

  It was reported that, during procedure, the device had no seal. There was no evidence of energy delivery and end tone was heard. Another handpiece was used with the same generator and it worked fine. There was no bleeding and there was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798066 ↗
• MalfunctionSep 17, 2026Peeled/Delaminated; Detachment of Device or Device Component

  It was reported that, during neck dissection on a total laryngopharyngectomy, the tip of the handpiece was chipped and damaged. Broken piece cannot be found. Another handpiece was used with the same generator and it worked fine. There was no additional intervention performed such as x-ray due to the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797998 ↗
• MalfunctionSep 17, 2026Energy Output Problem

  According to the reporter, during a procedure, the device had no seal (no evidence of energy delivery and end tones heard). Another device used with the same generator and worked fine. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797928 ↗
• MalfunctionSep 16, 2026Peeled/Delaminated; Detachment of Device or Device Component

  According to the reporter, during a wide resection of soft tissue tumor procedure in the foot, the tip of the device had chipped. Another device was reported to have been used successfully with the same generator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50786792 ↗
• MalfunctionSep 11, 2026Energy Output Problem

  It was reported that during the procedure, the device had no seal. There was no evidence of energy delivery, and end tones were heard. Another device was used with the same generator and it worked fine.

  Patient problems: Insufficient Information

  MAUDE report 50727905 ↗
• MalfunctionSep 11, 2026Peeled/Delaminated; Detachment of Device or Device Component

  It was reported that, during wide dissection of a soft tissue tumor, the tip of the handpiece was chipped. Another handpiece was used with the same generator and it worked fine. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727531 ↗
• MalfunctionSep 11, 2026Device Alarm System; Energy Output Problem

  It was reported that during a otorhinolaryngology procedure, the device had sealing failure during sealing the head and neck surrounding tissue. It was noted that the device had regrasp alert, end tone was heard and with evidence of energy delivery. Another device was properly used with the same generator. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50727479 ↗
• MalfunctionAug 12, 2026Retraction Problem; Difficult to Open or Close; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222956 ↗
• MalfunctionAug 6, 2026Energy Output Problem

  It was reported that, during a procedure, the handpiece had no seal. There was no no evidence of energy delivery and end tones were heard. Jaws were cleaned every time they got dirty. Another handpiece was used with the same generator and it worked fine. There was no bleeding and there was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159989 ↗
• MalfunctionAug 4, 2026Energy Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50130214 ↗
• MalfunctionJul 31, 2026Peeled/Delaminated; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101003 ↗
• MalfunctionJul 30, 2026Retraction Problem; Protective Measures Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084595 ↗
• MalfunctionJul 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064559 ↗
• MalfunctionJun 26, 2026Self-Activation or Keying; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS USED AND AFTER SOME TIME OF USE, THE DEVICE LOCKED IN THE CLOSED POSITION AND CONTINUED TO DELIVER COAGULATION UNINTERRUPTEDLY. THE DEVICE WAS REPLACED BY TWO OTHER DEVICES OF THE SAME REFERENCE/BATCH THAT SHOWED THE SAME MALFUNCTION DURING THE OPERATION. CHANGED THE DEVICE TO PREVENT PERMANENT INJURY OR IMPAIRMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638854 ↗
• MalfunctionJun 26, 2026Self-Activation or Keying; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS USED AND AFTER SOME TIME OF USE, THE DEVICE LOCKED IN THE CLOSED POSITION AND CONTINUED TO DELIVER COAGULATION UNINTERRUPTEDLY. THE DEVICE WAS REPLACED BY TWO OTHER DEVICES OF THE SAME REFERENCE/BATCH THAT SHOWED THE SAME MALFUNCTION DURING THE OPERATION. CHANGED THE DEVICE TO PREVENT PERMANENT INJURY OR IMPAIRMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638806 ↗
• MalfunctionJun 26, 2026Self-Activation or Keying; Difficult to Open or Close; Intermittent Energy Output

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS USED AND AFTER SOME TIME OF USE, THE DEVICE LOCKED IN THE CLOSED POSITION AND CONTINUED TO DELIVER COAGULATION UNINTERRUPTEDLY. THE DEVICE WAS REPLACED BY TWO OTHER DEVICES OF THE SAME REFERENCE/BATCH THAT SHOWED THE SAME MALFUNCTION DURING THE OPERATION. CHANGED THE DEVICE TO PREVENT PERMANENT INJURY OR IMPAIRMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638741 ↗
• MalfunctionJun 17, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A THYROIDECTOMY/THYROID GLAND RESECTION PROCEDURE WITH A USE OF THE DEVICE WITH A GENERATOR CONNECTED, INADEQUATE OR PARTIAL SEALING OCCURRED WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD, AND THE SEAL WAS REPORTED TO BLEED AFTER CUTTING. THE SEALING WAS POOR AND IT WAS STILL BLEEDING. ANOTHER DEVICE WAS REPORTED TO HAVE BEEN USED SUCCESSFULLY WITH THE SAME GENERATOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25528811 ↗
• MalfunctionJun 15, 2026Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE HAD SEALING INADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES H EARD). ANOTHER DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498258 ↗
• MalfunctionJun 15, 2026Peeled/Delaminated; Device Damaged Prior to Receipt by User; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, ALL SIX DEVICES ARRIVED BROKEN AND WERE IN UNUSABLE CONDITION. THE PHOTO SUBMITTED SHOWS TIP OF THE DEVICES WERE DAMAGED AND ONE DEVICE TIP HAD BROKEN OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25498229 ↗