LigaSure Precise LS1200Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884524001463), received between Apr 11, 2017 and Mar 24, 2022 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE STUDY, IN A CASE THAT DESCRIBES SUBCUTANEOUS CERVICOFACIAL EMPHYSEMA FOLLOWING THYROID SURGERY, 5 DAYS POST-OPERATIVELY, THE PATIENT PRESENTED TO A LOCAL HOSPITAL WITH SUDDEN ONSET NECK AND FACE SWELLING AFTER COUGHING. COMPUTED TOMOGRAPHY REVEALED EXTENSIVE SUBCUTANEOUS EMPHYSEMA OF THE NECK, FACE, UPPER THORAX AND MEDIASTINUM, WITH A POSSIBLE SITE OF TRACHEAL PERFORATION AT THE LEVEL OF C7. THE PATIENT WAS PROPHYLACTICALLY INTUBATED FOR TRANSPORT BACK TO THE METROPOLITAN HOSPITAL. HOWEVER, AS THE PATIENT WAS NEVER IN ANY RESPIRATORY DISTRESS AND THE USUAL SEQUELAE OF THE SURGICAL EMPHYSEMA IS USUALLY SELF-LIMITING, THE PATIENT WAS TREATED CONSERVATIVELY WITH INTRAVENOUS ANTIBIOTICS AND EXTUBATED THE NEXT DAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Internal Organ Perforation; Pulmonary Emphysema; Swelling/ Edema; Unintended Radiation Exposure

  MAUDE report 13894421 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A STUDY COMPARED COMPARE OUTCOMES OF LIGASURE (LS1200) VERSUS STANDARD LIGATURE TECHNIQUE AMONG WOMEN UNDERGOING ABDOMINAL HYSTERECTOMY BETWEEN JANUARY 2018 AND JANUARY 2020. THERE WERE 90 PATIENTS IN THE STUDY: 45 IN THE LIGASURE GROUP (GROUP II) AND 45 IN THE TRADITIONAL TECHNIQUE GROUP (GROUP I). LIGASURE GROUP POSTOPERATIVE COMPLICATIONS INCLUDED: POSTOPERATIVE BLOODLOSS (BLOOD IN THE INTRA-ABDOMINAL DRAIN), BLADDER INJURY (1 %) AND VESSEL INJURY (1 %). BLOOD TRANSFUSION (1%) WAS REQUIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12633570 ↗
• MalfunctionOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A STUDY COMPARED COMPARE OUTCOMES OF LIGASURE (LS1200) VERSUS STANDARD LIGATURE TECHNIQUE AMONG WOMEN UNDERGOING ABDOMINAL HYSTERECTOMY BETWEEN JANUARY 2018 AND JANUARY 2020. THERE WERE 90 PATIENTS IN THE STUDY: 45 IN THE LIGASURE GROUP (GROUP II) AND 45 IN THE TRADITIONAL TECHNIQUE GROUP (GROUP I). LIGASURE GROUP HAD INTRAOPERATIVE MEAN BLEEDING (270.44 ML).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12633447 ↗
• MalfunctionOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLI 20: ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM JANUARY 2011 UNTIL OCTOBER 2013, TWO HUNDRED AND EIGHT PATIENTS UNDERWENT THYROID SURGERY. SURGERY WAS PERFORMED IN 147 CASES (70.7 %) BY CONSULTANTS (CONSULTANT GROUP) AND IN 61 CASES (29.3 %) BY SURGICAL TRAINEES (TRAINEE GROUP). THE LIGASURE® PRECISE (COVIDIEN, BOULDER, CO, USA) WAS USED IN ALL CASES. POSTOPERATIVE HEMATOMA OCCURRED IN 7/208 PATIENTS OR 3.4%.

  Patient problems: Hematoma

  MAUDE report 9209328 ↗
• InjuryOct 18, 2019Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  PLI 10: ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM JANUARY 2011 UNTIL OCTOBER 2013, TWO HUNDRED AND EIGHT PATIENTS UNDERWENT THYROID SURGERY. SURGERY WAS PERFORMED IN 147 CASES (70.7 %) BY CONSULTANTS (CONSULTANT GROUP) AND IN 61 CASES (29.3 %) BY SURGICAL TRAINEES (TRAINEE GROUP). THE LIGASURE® PRECISE (COVIDIEN, BOULDER, CO, USA) WAS USED IN ALL CASES. THE RATE OF POSTOPERATIVE HEMORRHAGE WAS 3.4 % (7/208). AND THE INCIDENCE OF PERMANENT RECURRENT LARYNGEAL NERVE INJURY WAS 0.9 % (2 CASES).

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9207398 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE, THE AIM OF THIS STUDY WAS TO COMPARE THE EFFECT OF LIGASURE PRECISE (LP) AND NON-MEDTRONIC SCALPEL (HS) IN PATIENTS WHO HAD UNDERGONE TOTAL THYROIDECTOMY, BY HIGHLIGHTING THE POST-OPERATIVE PARATHYROID FUNCTION. A TOTAL OF 201 CONSECUTIVE PATIENTS FOR WHOM TOTAL THYROIDECTOMY HAD BEEN PLANNED WERE PROSPECTIVELY CLASSIFIED INTO TWO GROUPS. THERE WERE 104 PATIENTS IN LP GROUP AND 97 PATIENTS IN HS GROUP. ONE PATIENT OF THE LP GROUP HAD POST-OPERATIVE BLEEDING THAT REQUIRED RE-OPERATION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9195100 ↗
• MalfunctionApr 11, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THE DEVICE BROKE DURING USE ON A PATIENT. NO PATIENT INJURY REPORTED. ANOTHER DEVICE WAS OPENED TO CONTINUE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6483301 ↗