LigaSure LF1723Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10884521181588), received between Feb 9, 2016 and Oct 8, 2021 — classified as 2 deaths, 7 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (38 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. 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 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING COLONECTOMY, THE DEVICE JAW WAS DIFFICULT/IMPOSSIBLE TO OPEN. IT DID NOT LOCK ON TISSUE AND NO RESECTION NEEDED. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601003 ↗
• MalfunctionMay 19, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN. THE DEVICE WAS NOT APPLIED ON TISSUE WHEN THE EVENT HAPPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11849020 ↗
• MalfunctionApr 23, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING HYSTERECTOMY, THE DEVICE WAS DIFFICULT/UNABLE TO OPEN. IT WAS NOTED THAT THE JAWS WAS PARTIALLY OPENED. IT WAS APPLIED ON TISSUE BUT DID NOT. THEY SWITCHED THE HANDLE REPEATEDLY TO OPEN THE DEVICE. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713209 ↗
• MalfunctionOct 31, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING TESTING, THE DEVICE WAS DIFFICULT/IMPOSSIBLE TO OPEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10767455 ↗
• MalfunctionMar 2, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S JAWS WERE DIFFICULT TO OPEN.

  Patient problems: No Information

  MAUDE report 9773980 ↗
• MalfunctionNov 11, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE QUALITY OF THE SEALING OF THE DEVICE DECREASED AFTER 10 MINUTES OF USE. THEY USED A NEW DEVICE TO FINISH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9307214 ↗
• MalfunctionMay 29, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SEALING ABILITY WAS NOT WORKING AFTER THE TONE OF COMPLETED SEAL. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THE BLOODING COAGULATION ABILITY WAS AFFECTED BUT NO BLOOD TRANSFUSION WAS NECESSARY.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8651014 ↗
• MalfunctionMay 16, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DEVICE COAGULATION WAS INCOMPLETE WHICH RESULTS INTO BLEEDING. THERE WAS A RE-GRASP ALERT AND END TONE ALERT BUT NO EVIDENCE OF ENERGY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617728 ↗
• MalfunctionApr 30, 2019Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING ANTERIOR RESECTION WITH ILEOSTOMY COVERING, THE JAW OF THE INSTRUMENT WAS UNABLE TO CLOSE AND WHEN INSPECTED THEY SAW A SMALL PIN ON THE STERILE DRAPING SHEET OUTSIDE THE PATIENT'S ABDOMINAL CAVITY, AND A NEW DEVICE WAS USED. THE PATIENT HAD A SURGICAL SITE INFECTION DUE TO SURGERY AND DRESSING AND DEBRIDEMENT WAS DONE.

  Patient problems: Unspecified Infection

  MAUDE report 8564845 ↗
• MalfunctionApr 18, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING RADICAL THYROIDECTOMY, THE STIMULATION OF THE KNIFE HEAD WAS NOT COMPLETED, AND THE SURGEON USED A NEW DEVICE TO COMPLETE THE CASE. PATIENT INCURRED TEMPORARY TISSUE DAMAGE AND OOZING BLOOD IN THE AREA. PATIENT IS CURRENTLY STABLE.

  Patient problems: Tissue Damage

  MAUDE report 8528131 ↗
• InjuryFeb 18, 2019Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THORACO/LOBECTOMY, DURING USE OF THE DEVICE, AS IT WAS FOUND THAT THE INSULATION PART AT THE TIP WAS ABOUT TO PEEL OFF LIKE HANGNAIL AT THE FIRST SEALING, THE DEVICE WAS STOPPED USING. AFTER THE REPORT WAS RECEIVED, THE SALES REP TRIED TO CHECKED THE DEVICE, BUT THE HANGNAIL PART HAD PEELED OFF AND COULDN'T BE FOUND. THE INSULATION PART FELL INTO THE PATIENT'S CAVITY AND COULD NOT BE RETRIEVED. SURGICAL TIME WAS NOT EXTENDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8347642 ↗
• MalfunctionFeb 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TOTAL ABDOMINAL HYSTERECTOMY, THE WHITE PART OF THE JAWS CAME OFF BUT NOT INTO PATIENT'S CAVITY. NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318387 ↗
• MalfunctionFeb 7, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD NO SEAL. THERE WAS AN END TONE, BUT NO REGRASP ALARM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8315913 ↗
• MalfunctionJan 30, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING SUB TOTAL GASTRECTOMY, AFTER SQUEEZING THE HANDLE TO CLOSE THE JAWS, THE DOCTOR TRIED TO OPEN THE JAWS, BUT THE SITUATION BECAME THAT THE JAWS LOCKED AND JUST GOT HALF-OPENED. NO TISSUE RESECTION REQUIRED AND THE DEVICE DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. AFTER THAT, A NEW SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8291465 ↗
• MalfunctionJan 7, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING OOPHORECTOMY, AFTER PLUGGED IN THE DEVICE IN THE GENERATOR, IT APPEARED TO WORK FINE DUE TO THE SOUND OF SEALING CIRCLE BUT THERE WAS NO SEALING RESULT FOR THE TISSUE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8222689 ↗
• MalfunctionJan 4, 2019Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY, PARTIAL LUNG RESECTION, THE KNIFE CAME OUT FROM THE JAWS AND COULD NOT BE RETURNED IN THE MIDDLE OF THE PROCEDURE, BECAUSE THE DEVICE WAS NOT ABLE TO BE USED, ANOTHER NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. WHEN THE DEVICE WAS CHECKED, ALTHOUGH THE KNIFE WAS ALREADY STORED, BECAUSE THERE WERE MANY STAINS ON THE JAWS, THERE WAS A POSSIBILITY THAT THE KNIFE RETURN WAS HINDERED BY THE ATTACHMENT OF ESCHAR DUE TO INSUFFICIENT CLEANING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217621 ↗
• DeathDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE LEFT LOWER LOBECTOMY, THE BLOOD VESSELS TOUCHING THE OUTER SIDE OF THE JAWS OF THE LIGASURE FORMED A THROMBUS IN THE BLOOD VESSEL BY THERMAL DIFFUSION WHEN THE BLOOD VESSEL SHEATH PEELED OFF. DURATION OF PROCEDURE WAS ABOUT 2 HOURS. THERE WAS NOTHING ABNORMAL SEEN IN PARTICULAR WHILE MONITORING THE PATIENT POST PROCEDURE. CEREBRAL INFARCTION WAS ADMITTED A DAY POST PROCEDURE, AND THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CEREBRAL HERNIA DUE TO CEREBRAL INFARCTION.

  Patient problems: Death; Infarction, Cerebral; No Code Available; Thrombus

  MAUDE report 8125052 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A RIGHT UPPER LOBECTOMY, THE BLOOD VESSELS TOUCHING THE OUTER SIDE OF THE JAWS OF THE DEVICE FORMED A THROMBUS IN THE BLOOD VESSEL BY THERMAL DIFFUSION WHEN THE BLOOD VESSEL SHEATH PEELED OFF. THERE WAS NOTHING ABNORMAL SEEN IN PARTICULAR WHILE MONITORING THE PATIENT POST PROCEDURE. CEREBRAL INFARCTION WAS ADMITTED 2 DAYS POST PROCEDURE, AND THE PATIENT IS CURRENTLY ALIVE.

  Patient problems: Infarction, Cerebral; Thrombus

  MAUDE report 8125015 ↗
• MalfunctionDec 3, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN OPEN RADICAL PROSTATECTOMY, THE DEVICE WAS DIFFICULT TO OPEN AND CLOSE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8124005 ↗
• MalfunctionNov 15, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE IN THE MESENTERIC SECTION, THE SEALING COULD NOT COMPLETELY PERFORMED AND OOZING, BLEEDING OCCURRED, SO IT WAS DISCONTINUED TO USE. AN END TONE WAS HEARD. THE PROCEDURE WAS COMPLETED WITH MANUAL SUTURING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8074726 ↗
• MalfunctionNov 15, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO SEAL DURING USE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073910 ↗
• InjuryNov 12, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT UPPER LARGE AREA RESECTION (PA1+2C), AT THE FIRST SEALING, SEALING WAS PERFORMED WITHOUT LIGATION, AT THAT TIME THERE WAS NO PROBLEM, BUT MAJOR BLEEDING OCCURRED FROM THE SAME LOCATION AFTER 5 MINUTES. THE VIDEO WAS CHECKED, THE PRODUCT WAS NOT DIRTY, AND IT WAS NOT TENSIONED. DISSECTION DISTANCE WAS ENOUGH, THE PRODUCT WAS USED AT THE SLIGHTLY ROOT SIDE OF THE CENTER OF THE JAWS. AND AFTER SEALING, THE SAME LOCATION WAS NOT TOUCHED AT ALL. THE SEALING WAS A FAST SEAL FOR ABOUT 1 SECOND. WHEN CHECKING THE VIDEO, IT WAS NOTICED THAT BOTH SIDES OF THE JAWS WERE BURNED, BUT IT SEEMED LIKE IT WAS NOT SEALED ONLY INSIDE THE JAW. THERE WAS TISSUE DAMAGE AND TISSUE REPAIR WERE NECESSARY TO STOP THE BLEEDING BY FIBRIN SEALANT PATCH. MORE THAN 500 CC OF BLEEDING OCCURRED BECAUSE OF THE ISSUE, BUT NO BLOOD TRANSFUSION WAS REQUIRED. THERE WAS NO RE-GRASP ALERT, AND THERE WAS A SEALING TONE AND END TONE.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 8058714 ↗
• InjuryNov 5, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING AN OPERATION OF THORACO/LOBECTOMY IT WAS DOUBLE SEALED AND RESECTED IN. AT THIS TIMING, THERE WAS NO PROBLEM WITH THE HEMOSTASIS AND RESECTION WAS COMPLETED AND AN END TONE WAS HEARD. AFTER THE OPERATION, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) AND THE BLOOD PRESSURE DECREASED AFTER ABOUT 1-2 HOURS. AS THE RESULT OF CONFIRMING BY COMPUTED TOMOGRAPHY (CT), LESS THAN 500CC OF BLEEDING WAS FROM THE END SEGMENT OF PA WHICH WAS SEALED. THE REOPERATION WAS DONE BY OPEN SURGERY BY PIERCING LIGATION AND THE PATIENT ALSO HAD BLOOD TRANSFUSION. IT WAS NOT BLEEDING FROM ONE PART OF THE END SEGMENT, BUT FROM SEVERAL PARTS. THE USED DEVICE WAS DISPOSED AND WOULD NOT BE RETURNED.

  Patient problems: No Code Available

  MAUDE report 8039913 ↗
• MalfunctionOct 22, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING SURGERY, THE DEVICE DID NOT SEAL. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7990885 ↗
• MalfunctionOct 19, 2018Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO PROMPT THE CORRECT TONE, UNABLE TO SEAL AND CLOSE THE TISSUE AND WAS UNABLE TO STOP THE BLEEDING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985052 ↗