LigaSure LF1737Recalls & reported problems

Summary

The FDA's MAUDE database contains 469 adverse event reports that list this exact device (DI 10884521181571), received between Feb 11, 2016 and Oct 5, 2023 — classified as 2 deaths, 25 injuries, 442 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (131 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 469 reports, in the reporter's own words as published by the FDA.

• DeathOct 5, 2023Energy Output Problem; Adverse Event Without Identified Device or Use Problem; Energy Output Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED TO SEAL A PULMONARY ARTERY. AFTER THE SURGERY WAS COMPLETED, IT WAS NOTED THAT THERE WAS BLEEDING FROM A PULMONARY ARTERY. TACHOSIL, LIGATURE THREAD, AND A LIGASURE DEVICE WERE ALL USED IN CONTROLLING THE BLEEDING. THE 5MM DIAMETER PULMONARY ARTERY WAS LIGATED WITH A THREAD, SEALED WITH LIGASURE ONCE, AND DISSECTED. THE PATIENT WAS CLOSED UP AND REPOSITIONED, WHEN BLOOD WAS NOTICED MIXED IN THE DRAIN. THE CHEST WAS REOPENED WHERE THERE WAS HEAVY BLEEDING, AND THE PATIENT WENT INTO CARDIAC ARREST DESPITE REOPERATION, AND DIED. THE ARTERY IN QUESTION APPEARED TO STILL BE CIRCULAR IN SHAPE, EVEN AFTER LIGASURE USE, AND THE SUTURE WASN'T FOUND. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED THE SEAL REOPENING, HEAVY BLEEDING, CARDIAC ARREST, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REOPENING OF THE SURGICAL SIGHT. INFORMATION RECEIVED INDICATES THE PATIENT IS NOW DECEASED, DUE TO HEAVY BLEEDING THAT LEAD TO CARDIAC ARREST.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 17882713 ↗
• MalfunctionApr 4, 2023Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPICALLY ASSISTED DISTAL GASTRECTOMY, THE PRODUCT WAS USED TO SEAL THE OMENTUM, BUT THE CUTTING TRIGGER FELT STRANGE. THE JAWS COULD NOT BE OPENED AND THE IT COULD NOT BE RELEASED WHEN SQUEEZED. IT WAS MANAGED TO BE RELEASED SOMEHOW. FELT LIKE THE WIRE CONNECTING THE JAWS AND THE HANDLE HAD BEEN CUT OR THE TISSUE MIGHT HAVE BEEN CLAMPED TOO MUCH. AS FOR THE SEAL, DISSECTION COULD BE DONE WITHOUT ANY PROBLEM AT ALL, BUT ITS USE WAS STOPPED TO BE SAFE AND A NEW PRODUCT WAS TAKEN OUT AND USED. THERE WERE NO PROBLEM WITH THE NEWLY OPENED PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676156 ↗
• MalfunctionDec 8, 2022Device Alarm System; Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output; Device Alarm System; Energy Output Problem; Difficult or Delayed Activation; Intermittent Energy Output

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER THE DEVICE WAS ACTIVATED, THE REQUIRED COAGULATION EFFECT COULD NOT BE ACHIEVED. DEVICE WAS DIFFICULT TO ACTIVATE. A NEW LIGASURE WAS REPLACED USING THE SAME GENERATOR AND IT WORKED FINE. THERE WAS AN ACTIVATION HEARD. NO RE-GRASP AND NO END TONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939422 ↗
• MalfunctionJul 28, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THEY ACTIVATE DEVICE AFTER CLOSURE, AND IT WAS NON-REACTIVE. ANOTHER DEVICE WAS USED AND WORKED FINE. BASED ON THE INVESTIGATION, OVER MOLD WAS DAMAGED, AND PIECES OF THE OVER MOLD WERE MISSING. NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15123118 ↗
• MalfunctionNov 16, 2021Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE INCISIONAL HERNIA PROCEDURE, THE DEVICE WAS NOT ABLE TO COMPLETE THE SEAL CYCLE. THIS EVENT HAPPENED IN THE 1ST GRASP ITSELF AND DID NOT ADVANCE TO ANY BLOOD VESSEL. THERE WAS AN ACTIVATION TONE HEARD. AFTER FIRST FAILURE, THEY HAD CLEANED IT AND TRIED FEW MORE TIMES AND THE HAND INSTRUMENT CONTINUED WITH THE SAME ERROR OF INCOMPLETE SEAL CYCLE. AFTER SEEING THE ISSUE, THE SURGEON SWITCHED ON TO OTHER INSTRUMENT AND THE SURGERY WAS SAFELY COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819310 ↗
• MalfunctionSep 7, 2021Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DISSECTOR TIP FAILED TO PROPERLY COAGULATE AND CLOSE THE TISSUE AND STOP BLEEDING. THERE WAS NO REGRASP ALARM REPORTED. THERE WAS NO END TONE HEARD. ANOTHER DEVICE WAS USED AS A RESOLUTION. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434422 ↗
• MalfunctionMar 31, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE JAWS WERE DIFFICULT/IMPOSSIBLE TO OPEN. THE JAWS WERE PARTIALLY OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11600341 ↗
• DeathMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, A PATIENT DEATH OCCURRED DURING A PROCEDURE WHERE THIS DEVICE WAS USED. THE ISSUE INVOLVED BLEEDING, BUT SPECIFIC DETAILS SUCH AS THE CAUSE OF DEATH ARE UNKNOWN. THE FACILITY DOESN'T BELIEVE THAT THE PRODUCT HAD A MALFUNCTION. THE EVENT HAS NOT BEEN IDENTIFIED AS BEING DUE TO THE DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 11586161 ↗
• MalfunctionMar 4, 2021Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING IPOM PLUS, THE KNIFE WAS NOT GETTING RETRACTED. AS A RESULT IT WAS IMPOSSIBLE TO CLOSE THE JAW AND SEAL. THEY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11414454 ↗
• MalfunctionJan 29, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTAL SURGERY PROCEDURE, BLOOD COAGULATION DID NOT COMPLETED AND THE MACHINE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11251135 ↗
• MalfunctionJan 4, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING RADICAL GASTRIC CANCER SURGERY, NO ENERGY WAS FIRED WHEN THE GASTRIC OMENTUM TISSUE WAS CLAMPED. THERE WAS NO BLEEDING OCCURRED. IT WAS NOTED THAT THERE WAS NO RE-GRASP BUT END TONE WAS HEARD. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE.

  Patient problems: Insufficient Information

  MAUDE report 11107602 ↗
• MalfunctionDec 28, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) ESOPHAGECTOMY. A SMALL PIECE OF METAL THAT FELL OFF THE JAW OF THE DEVICE. THE PIECE FELL ONTO THE CASE CART WHEN IT WAS BROKEN. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077281 ↗
• MalfunctionNov 25, 2020Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HAND PIECE'S JAWS OF THE DEVICE WAS DIFFICULT TO OPEN, IT WAS ONLY ABLE TO PARTIALLY OPEN AND THE KNIFE BLADE DID NOT RETRACT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905269 ↗
• InjuryNov 10, 2020Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT WORK WHEN ACTIVATING THE COAGULATION BUTTON. THE GENERATOR WAS REPLACED BUT IT STILL DID NOT WORK. THE SURGERY STARTED BY VIDEO WITH THE DEVICE INDICATED FOR THIS SURGERY, HOWEVER WITH THE NON-FUNCTIONING OF THE DEVICE, IT WAS NOT FEASIBLE TO PROCEED WITH THE VIDEO SURGERY, SO THE SURGERY WAS CONVERTED TO THE CONVENTIONAL "OPEN" FORM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10816696 ↗
• MalfunctionOct 29, 2020Self-Activation or Keying; Intermittent Energy Output; Self-Activation or Keying; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THE SLEEVE GASTRECTOMY, BOTH DEVICE'S SEAL CYCLE WAS TOO LONG THEN IT ENDED WITH INCOMPLETE SEAL CYCLE FEEDBACK. THERE WERE NO RE-GRASP ALERT, NO EVIDENCE OF ENERGY DELIVERY AND NO END TONE, BUT THERE WAS AN ACTIVATION TONE. THERE WERE SUCCESSFUL SEALS MADE BEFORE THE ISSUE OCCURRED, BUT MOSTLY THE SEAL CYCLE TOOK A LONG TIME THEN WOULD GIVE INCOMPLETE SEAL CYCLE ERROR. THE DOCTORS WERE AFRAID TO CUT ALTHOUGH TISSUE HAVE BEEN SEALED BUT THERE WAS NO ANY FEEDBACK JUST THE INCOMPLETE SEAL CYCLE ERROR SO ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10754383 ↗
• MalfunctionOct 8, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ENERGY WAS DELIVERED, BUT THE SEALING PERFORMANCE WAS NOT AS GOOD AS USUAL. THERE WAS A RE-GRASP (&) ENDTONE. THEY REPLACED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10652481 ↗
• MalfunctionAug 31, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD INADEQUATE SEAL AND HAD BLEEDING AFTER THE PROCEDURE.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10470699 ↗
• MalfunctionAug 27, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE SMOKE WAS OBSERVED BUT THE DEVICE SEALING PERFORMANCE IS FAR LESS THAN USUAL. THE RE-GRASP, END TONE AND ENERGY DELIVERY WAS PRESENT. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10459878 ↗
• MalfunctionAug 13, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RADICAL RESECTION OF SIGMOID COLON ADENOCARCINOMA, WHEN THE SURGICAL CLOSED CUTTER WAS USED, THE ELECTROCOAGULATION WAS INEFFECTIVE AND THE TISSUE AT THE CUT SITE WAS BLEEDING. THEY USED A DISSECTOR INSTEAD OF CUTTING TO STOP BLEEDING.

  Patient problems: No Information

  MAUDE report 10401644 ↗
• MalfunctionJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE JAW OF THE DEVICE WAS DAMAGED. A PART OF THE TIP HAD DISENGAGED BUT NOTHING FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10254960 ↗
• MalfunctionJun 30, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE DOES NOT COAGULATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213484 ↗
• MalfunctionApr 14, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HYSTERECTOMY, THE SURGEON WAS UNABLE TO OPEN THE JAW WHEN THE HAND PIECE ENTERED TO THE ABDOMINAL CAVITY. TOOK THE HAND PIECE OUTSIDE AND FOUND THE JAW FAILED TO OPEN, SO SURGEON USED BIPOLAR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957523 ↗
• MalfunctionApr 7, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A PARTIAL SEAL. BOTH END TONES AND ALARMS WERE HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Information

  MAUDE report 9932163 ↗
• MalfunctionMar 20, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC SLEEVE, THE HAND PIECE'S COAGULATION WAS INADEQUATE BUT CUT WAS OKAY. ANOTHER HAND PIECE WAS USED WITHOUT ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860688 ↗
• MalfunctionFeb 27, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE LIGASURE DEVICE HAD A SEAL ISSUE WITH A REGRASP ALERT AND END TONE HEARD.

  Patient problems: No Information

  MAUDE report 9763370 ↗