LigaSure LF1744Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 10884521181564), received between Feb 8, 2016 and Feb 8, 2023 — classified as 7 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (21 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE JAW BROKE. NOTING FELL INTO THE PATIENT'S CAVITY. WHEN THE SURGEON SAW IT, HE IMMEDIATELY TOOK OUT THE DEVICE. THE VISUAL INSPECTION FOUND THE DEVICE'S BOTTOM JAW HAD DISENGAGED AND WAS NOT RETURNED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16322736 ↗
• MalfunctionMar 2, 2021Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DEVICE STOPPED WORKING AND SEAL WAS NOT HAPPENING. THE INSTRUMENT WORKED FOR FIRST HALF OF THE SURGERY. THERE WAS AN END TONE BUT NO REGRASP ALERT AND NO ENERGY DELIVERY. SURGERY WAS COMPLETED BY BIPOLAR INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11400232 ↗
• MalfunctionJan 8, 2021Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE'S KNIFE BLADE DID NOT RETRACT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11138725 ↗
• MalfunctionFeb 26, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE HAD A SEAL ISSUE WITH REGRASP ALERT AND END TONE HEARD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9758882 ↗
• InjuryOct 14, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A BARIATRIC SURGERY, THE DEVICE HAD A INADEQUATE SEAL AND A BLOOD LOSS OF LESS THAN 250CC 10 MINUTES AFTER THE PROCEDURE. NO BLOOD TRANSFUSION PERFORMED. SOME OF THE SEAL SITES WAS FOUND RE-OPENED. THE ISSUE WAS RESOLVED BY SUTURING THE SITE.

  Patient problems: No Code Available; No Information

  MAUDE report 9183973 ↗
• MalfunctionFeb 6, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FAILED TO SEAL AND THEREFORE HAD TO BE REPLACED BY ANOTHER DEVICE. ONLY THE END TONE WAS HEARD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8311665 ↗
• MalfunctionJan 29, 2019Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, THE TISSUE WAS STICKING TO THE JAWS OF THE DEVICE AFTER ACTIVATION DURING THE SURGERY. CAUSED AN INCREASE IN OR TIME AND CONCERN ON BEHALF OF SURGEON OF INCREASED BLEEDING. STICKING HAPPENED WITH ONE HAND INSTRUMENT AND THEN ANOTHER HAND DEVICE WAS OPENED AND IT RESPONDED THE SAME WAY. THE SURGEON HAD TO PULL THE TISSUE AWAY FROM THE JAWS OF THE INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287812 ↗
• MalfunctionJan 29, 2019Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, THE TISSUE WAS STICKING TO THE JAWS OF THE DEVICE AFTER ACTIVATION DURING THE SURGERY. CAUSED AN INCREASE IN OR TIME AND CONCERN ON BEHALF OF SURGEON OF INCREASED BLEEDING. STICKING HAPPENED WITH ONE HAND INSTRUMENT AND THEN ANOTHER HAND DEVICE WAS OPENED AND IT RESPONDED THE SAME WAY. THE SURGEON HAD TO PULL THE TISSUE AWAY FROM THE JAWS OF THE INSTRUMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287807 ↗
• MalfunctionDec 21, 2018Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHEN IT WAS CONNECTED TO GENERATOR, AT THE TIME OF RESECTION- AT ABOUT THE 10TH SEALING; IT WAS STATED THAT THE INNER SIDE OF THE JAWS PEELED OFF AFTER THE DEVICE WAS RELEASED FROM THE TISSUE. IT WAS STILL CONNECTED BY A PART OF THE TIP, IT WAS NOT COMPLETELY REMOVED. IT SEEMED THAT THERE WAS NO PROBLEM WITH THE SEAL ITSELF. AFTER THAT, A NEW PRODUCT WAS USED WITHOUT PROBLEM, SO THE OPERATION WAS CONTINUED. NOTHING FELL INTO THE PATIENT'S CAVITY. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8191946 ↗
• InjuryNov 30, 2018Retraction Problem; Difficult to Open or Close; Mechanical Jam; Retraction Problem; Difficult to Open or Close; Mechanical Jam

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING THE ROBOT ASSISTED SURGERY FOR PROSTATE CANCER. WHEN THE DEVICE WAS USED TO SEAL THE TISSUE AT THE 1ST SEALING, THE KNIFE DID NOT RETURN AND THE JAWS DID NOT OPEN. EVEN TRIED TO RELEASE THE JAWS, THE JAWS COULD NOT BE OPENED, SO A NEW DEVICE WAS OPENED AND IT WAS USED TO SEAL THE TISSUE AROUND THE JAWS OF REPORTED DEVICE. THE REPORTED DEVICE WAS REMOVED FROM THE CAVITY. THE DEVICE WAS REMOVED FROM THE TISSUE BY ADDITIONALLY RESECTING THE TISSUE. THEN THE OPERATION WAS COMPLETED WITHOUT ANY DELAY.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8119678 ↗
• MalfunctionNov 26, 2018Material Fragmentation; Peeled/Delaminated; Material Fragmentation; Peeled/Delaminated

  ACCORDING TO THE REPORTER, THE HAND INSTRUMENT WAS CONNECTED TO THE GENERATOR AND THE SEALING COULD BE PERFORMED WITHOUT PROBLEM. HOWEVER, IN THE MIDDLE OF THE OPERATION, THE FRAGMENTS LIKE INSULATION PART FELL INTO THE PATIENT'S CAVITY AND ALL THE FRAGMENTS WERE COLLECTED BY FORCEPS. TO DEAL WITH THE EVENT, A NEW DEVICE WAS OPENED AND USED WITHOUT PROBLEM. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104776 ↗
• MalfunctionNov 26, 2018Break; Break

  ACCORDING TO THE REPORTER, WHILE THE DEVICE WAS USED WITH GENERATOR, THE TIP OF THE DEVICE WAS BROKEN. THE SALES REP WILL VISIT THE CUSTOMER'S FACILITY TO CONFIRM THE LOT NUMBER AND THE DEVICE. HE/SHE WILL REPORT THE LOT AND DEVICE'S CONDITION WHEN THE INFORMATION IS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NOTHING FELL INTO THE PATIENT'S CAVITY. NO PATIENT HARM. INITIAL INVESTIGATION FOUND THE BOTTOM JAW OVERMOLD WAS DAMAGED AND MISSING PLASTIC. THE DISENGAGED PLASTIC WAS RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8101416 ↗
• InjuryOct 31, 2018Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT COLECTOMY WITH ENBLOC ABDOMINAL WALL RESECTION, THE TRIGGER JAMMED AND COULD NOT CUT THE TISSUE WHICH CAUSED EXCESS BLEEDING. THE SURGEON HAD TO TRANSECT MORE TISSUE THAN PLANNED. THEY REPLACED WITH ANOTHER HOOK.

  Patient problems: Blood Loss; Tissue Damage

  MAUDE report 8025543 ↗
• MalfunctionJul 6, 2018Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BLADE DID NOT RETURN AND GOT EXPOSED. THEY CHANGE TO LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7666390 ↗
• InjuryJun 15, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT HAD BLEEDING THE SAME DAY AS THE PROCEDURE AND THE SURGEON SUSPECTED IT WAS FROM THE SEALED OMENTUM. DURING A SLEEVE GASTRECTOMY, THE SURGEON NOTED THAT THE SEAL QUALITY WAS NOT OPTIMAL WITH A BLEED OCCURRING JUST AFTER A SEAL. THE PATIENT LOST ROUGHLY A LITER OF BLOOD WHICH REQUIRED A LAPAROSCOPIC WASH OUT AND DRAIN.

  Patient problems: Blood Loss

  MAUDE report 7607061 ↗
• MalfunctionJun 15, 2018Energy Output To Patient Tissue Incorrect; Failure to Cut; Energy Output To Patient Tissue Incorrect; Failure to Cut

  ACCORDING TO THE REPORTER, DURING GENERAL SURGERY, THE USER OPENED THE LIGASURE AND WAS NOT SATISFIED WITH THE QUALITY OF SEALING AND CUT. SO THEY ASKED THE CIRCULATING NURSE TO OPEN A NEW DEVICE AND IT WORKED WELL NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7606775 ↗
• InjuryMay 22, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, AFTER GASTRIC SLEEVE PROCEDURE, THE SURGEON STATED HE FELT THERE WAS FAR LESS BLEEDING DURING THE PROCEDURE WITH THE DEVICE, SURGICAL SPACE WAS CLEAN AND NO VISIBLE SIGN OF BLEEDING. THE PATIENT WAS DISCHARGED AT ABOUT 12:00PM. THEN, LATER THAT EVENING THE PATIENT RETURNED TO THE HOSPITAL WITH PAIN, AND LOOKED PALE. SHE WAS TAKEN TO OPERATING ROOM AND THEY FOUND A SHORT GASTRIC BLEED AND INTERVENTION WAS REQUIRED TO STOP THE BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 7534647 ↗
• MalfunctionMay 21, 2018Detachment Of Device Component; Peeled/Delaminated; Detachment Of Device Component; Peeled/Delaminated

  ACCORDING TO THE REPORTER, AFTER FEW MINUTES OF USING THE DEVICE IN A SLEEVE GASTRECTOMY PROCEDURE, A PART OF THE GREY INSULATION FROM THE FIXED JAW BECAME DETACHED AND FELL INSIDE THE ABDOMINAL CAVITY OF THE PATIENT. THEY WERE ABLE TO LOCATE AND RETRIEVE THE COMPONENT. THEY USED A NEW DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530018 ↗
• MalfunctionApr 26, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE LOCKED AND WAS NO LONGER ABLE TO BE USED.

  Patient problems: No Information

  MAUDE report 7464537 ↗
• MalfunctionApr 17, 2018Self-Activation or Keying; Device Displays Incorrect Message; Self-Activation or Keying; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE THEY CONNECTED DEVICE TO A GENERATOR, HOWEVER AN ERROR SOUND WAS HEARD IMMEDIATELY. THE GENERATOR WAS REPLACED BY ANOTHER GENERATOR, AND THE SAME EVENT OCCURRED. AFTER THAT, THE ERROR SOUND STOPPED AND THE PHYSICIAN USED THE DEVICE AS USUAL, HOWEVER THE SEALING WAS PERFORMED WITHOUT ACTIVATION. ALSO, AN ACTIVATION SOUND WAS HEARD WITHOUT PRESSING THE BUTTON WHEN THEY SET THE DEVICE ON THE SURGICAL TABLE.

  Patient problems: No Information

  MAUDE report 7436170 ↗
• InjuryFeb 25, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING A BARIATRIC SLEEVE PROCEDURE, THE DEVICE DID NOT SEAL. WHEN SEALING VESSELS, THE SURGEON HEARD AN END TONE AND RELEASED THE DEVICE, BUT THE TISSUE WAS NOT SEALED AND BLEEDING RESULTED. SURGICAL INTERVENTION WAS REQUIRED TO PREVENT FURTHER BLEEDING BY USING MANUAL CLIPS AND SUTURES IN ORDER TO LIGATE THE VESSELS. THE DEVICE WAS REMOVED AND PRESSURE APPLIED. THE VESSELS WERE LIGATED BUT TOOK THIRTY MINUTES DUE TO THE BLEEDING. BLOOD LOSS WAS MORE THAN 500CC, HOWEVER NO TRANSFUSION WAS REQUIRED. FT10 GENERATOR WAS USED DURING THE EVENT.

  Patient problems: Blood Loss

  MAUDE report 7295233 ↗
• MalfunctionFeb 19, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD INADEQUATE SEAL THAT LEAD TO DELAYED BLEEDING OF THE OPERATION SITE. THE BLEEDING OCCURRED DURING A SINGLE PROCEDURE AND NO RE-OPERATION WAS REQUIRED. THERE WAS NO ALARMS AND NO TRANSFUSION WAS REQUIRED. NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7281061 ↗
• MalfunctionDec 27, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT AFTER APPROXIMATELY TWO HOURS OF USE, THE LOWER RIGHT SECTION OF THE JAWS BECAME DAMAGED AND DISENGAGED. THE DEVICE WORKED FINE PRIOR TO THE ISSUE. THE ISSUE WAS NOTICED AFTER THE DEVICE WAS RELEASED FROM THE TROCAR. NOTHING FELL INTO THE PATIENT CAVITY. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE WITHOUT ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148886 ↗
• MalfunctionDec 22, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT SEAL. THE SEAL CYCLE WAS COMPLETED BUT THE DEVICE DID NOT SEAL THE VESSEL. AN ABSENCE OF A REGRASP ALERT WAS NOTED. THERE WAS AN END TONE HEARD AND EVIDENCE OF ENERGY DELIVERY. THE SURGEON HAD TO USE THREE SUTURES TO SEW AND CLOSE THE VESSEL. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7144799 ↗
• MalfunctionNov 29, 2017Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE JAW WOULD NOT OPEN WHEN THE HANDLE WAS RELEASED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7069802 ↗