LigaSure Impact LF4318Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521165311), received between Mar 10, 2016 and Mar 24, 2022 — classified as 3 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (14 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 50 reports, in the reporter's own words as published by the FDA.

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

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED LAST JUNE 2027 TO JUNE 2020, THE STUDY OBJECTIVE WAS TO COMPARE SURGICAL OUTCOMES BETWEEN TRANSVAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY FOR HYSTERECTOMY (VNOTESH) AND TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) FOR THE BENIGN UTERINE DISEASES. A RETROSPECTIVE REVIEW OF ELECTRONIC MEDICAL RECORDS OF WOMEN THAT UNDERWENT VNOTESH WITH LIGASURE IMPACT BETWEEN JANUARY 2019 AND JUNE 2020 (N=33) AND TLH BETWEEN JUNE 2017 AND AUGUST 2019 (N=33) IN BANGKOK HOSPITAL UDON, UDONTHANI PROVINCE, THAILAND WAS CARRIED OUT. POST-OP COMPLICATIONS OF BLEEDING OCCURRED IN 2 (6.1%) PATIENTS IN THE LIGASURE GROUP.

  Patient problems: Insufficient Information

  MAUDE report 13894609 ↗
• MalfunctionNov 19, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE DEVICE HAD INADEQUATE SEAL AND BLEEDING AFTER PROCEDURE. THERE WAS AN END TONE HEARD BUT THERE WAS NO REGRASP ALERT AND NO EVIDENCE OF ENERGY DELIVERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846634 ↗
• MalfunctionJul 21, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S JAWS WERE DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202572 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED HYSTERECTOMIES PERFORMED WITH TRADITIONAL CUTTING AND TYING TOOLS AND TH OSE PERFORMED WITH LIGASURE INSTRUMENTS IN PATIENTS WITH KNOWN PLACENTAL INSERTION ANOMALIES BETWEEN 2013 AND 2019. THERE WERE 28 PATIENTS IN THE LIGASURE GROUP AND POST-OPERATIVE COMPLICATIONS INCLUDED: TRANSFUSIONS, BLADDER REPAIR AND POST-OPERATIVE INFECTION. I NTERVENTIONS FOR BLADDER REPAIR AND INFECTION NOT LISTED. THE EFFICACY OF LIGASURETM OPEN INSTRUMENTS IN CASES OF CESAREAN HYSTERECTOMY DUE TO PLACENTA PERCRETA: A RETROSPECTIVE, RECORD-BASED, COMPARATIVE STUDY: ZEYNEB BAKACAK, 2020, TAYLOR AND FRANCIS.

  Patient problems: Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11250074 ↗
• MalfunctionMar 30, 2020Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE KNIFE BLADE DID NOT RETRACT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9898196 ↗
• MalfunctionOct 31, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT SEAL. THEY OPENED ANOTHER DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9264011 ↗
• InjuryAug 27, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY THE DEVICE HAD INADEQUATE SEAL. THERE WAS A BLEEDING AFTER THE PROCEDURE.

  Patient problems: Blood Loss

  MAUDE report 8937033 ↗
• MalfunctionMay 29, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING OPEN RIGHT COLECTOMY RESECTION, THE DEVICE DID NOT SEAL BUT HEARD THE NORMAL TONE. THE SAME PROBLEM OCCURS WHEN THREE INSTRUMENTS ARE CONTINUOUSLY REPLACED. A NEW DEVICE WAS REPLACED AND THE OPERATION WAS COMPLETED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8652116 ↗
• MalfunctionMay 29, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING OPEN RIGHT COLECTOMY RESECTION, THE DEVICE DID NOT SEAL BUT HEARD THE NORMAL TONE. THE SAME PROBLEM OCCURS WHEN THREE INSTRUMENTS ARE CONTINUOUSLY REPLACED. A NEW DEVICE WAS REPLACED AND THE OPERATION WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8652113 ↗
• MalfunctionMay 29, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING OPEN RIGHT COLECTOMY RESECTION, THE DEVICE DID NOT SEAL BUT HEARD THE NORMAL TONE. THE SAME PROBLEM OCCURS WHEN THREE INSTRUMENTS ARE CONTINUOUSLY REPLACED. A NEW DEVICE WAS REPLACED AND THE OPERATION WAS COMPLETED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8650537 ↗
• MalfunctionMay 2, 2019Protective Measures Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE KNIFE BLADE CAME OUT DURING SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575736 ↗
• MalfunctionMar 18, 2019Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, AT AROUND 30 MINUTES PASSED FROM THE PROCEDURE STARTED, ERROR OCCURRED FREQUENTLY EVEN THOUGH CLEANING THE TIP OF THE DEVICE WAS DONE. BOTH SEALING TONE AND END TONE WERE ALSO HEARD. ANOTHER DEVICE WAS USED INSTEAD. THERE WAS NO BLEEDING OR BLOOD TRANSFUSION.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 8429735 ↗
• MalfunctionMar 8, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING CYSTECTOMY/ ILEAL CONDUIT, THE DEVICE WAS ACTIVATED BUT IT DID NOT SEAL. THEY DID A HIGHER ACTIVATION BUT STILL THEY GOT NO SEAL. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THEY DEVICE WAS ACTIVATED WITH NO GRASP ALARM BUT IT HAS SEALING TONE AND END TONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8405560 ↗
• InjuryFeb 18, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING CYSTOPROSTATECTOMY, THE DEVICE WAS ABLE TO ACTIVATE NORMALLY AND PRODUCED END TONE, BUT THE PHYSICIAN COULD NOT STOP BLEEDING. HEMOSTASIS WAS PERFORMED AS THE FOLLOWING STEPS: THE USE OF THE DEVICE TO STOP BLEEDING AND WHEN HEMOSTASIS FAILED, THEY USED A DIFFERENT DEVICE TO STOP BLEEDING, BUT FAILED TO STOPPED BLEEDING EITHER, UNIT THEY USED THE METHOD OF SOFT COAGULATION. ALSO, THE ACTIVATION SETTING WAS CHANGED TO BAR 3 FROM BAR 2, HOWEVER, THE METHOD DID NOT HAVE EFFECT. BLOOD TRANSFUSION WAS DONE TO PATIENT AT THE END OF THE PROCEDURE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8347707 ↗
• MalfunctionJan 22, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE HAND INSTRUMENT HAD NO SUCCESSFUL SEALS ON TISSUE WHEN IT WAS ACTIVATED DURING USE ON A STOMACH SURGERY. THERE WAS NO RE-GRASP ALERT, BUT THERE WAS AN ACTIVATION TONE. NO BLEEDING AND THERE WAS NO NEED FOR BLOOD TRANSFUSION REQUIRED. THE SURGERY TIME WAS NOT EXTENDED BY 30 MINUTES OR MORE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266600 ↗
• MalfunctionDec 21, 2018Retraction Problem; Protective Measures Problem; Retraction Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL BLADDER RESECTION, ALTHOUGH THE TISSUE WAS HARD, THE KNIFE CAME OUT OF THE RAIL OF THE KNIFE AT THE TIP OF THE JAWS AND THE KNIFE BLADE DID NOT RETRACT THUS THE DEVICE BECAME USELESS. THE DEVICE WAS REMOVED BY FORCIBLY DISCONNECTED BY CLAMPING WITH THE JAWS OF DEVICE. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE AND THE OPERATION WAS FINALLY CONTINUED WHEN USING THE THIRD DEVICE.

  Patient problems: No Information

  MAUDE report 8189444 ↗
• MalfunctionDec 21, 2018Retraction Problem; Protective Measures Problem; Retraction Problem; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING A TOTAL BLADDER RESECTION, ALTHOUGH THE TISSUE WAS HARD, THE KNIFE CAME OUT OF THE RAIL OF THE KNIFE AT THE TIP OF THE JAWS AND THE KNIFE BLADE DID NOT RETRACT THUS THE DEVICE BECAME USELESS. THE DEVICE WAS REMOVED BY FORCIBLY DISCONNECTED BY CLAMPING WITH THE JAWS OF DEVICE. THE SAME EVENT OCCURRED WITH THE SECOND DEVICE AND THE OPERATION WAS FINALLY CONTINUED WHEN USING THE THIRD DEVICE.

  Patient problems: No Information

  MAUDE report 8189435 ↗
• MalfunctionDec 20, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE GASTRECTOMY, THE TISSUE WAS CLAMPED AND THE DEVICE ACTIVATED (THE FIRST SEALING). THE JAWS WERE TRYING TO BE OPENED, BUT FAILED. THE HANDLE WAS BACK TO ITS ORIGINAL POSITION, BUT ONLY THE JAWS KEPT CLOSING. REPLACED WITH A NEW HANDLE AND IT WAS USED WITH NO PROBLEM. THE OPENING AND CLOSING OF THE RETURNED HANDLE WAS TESTED FOR MANY TIMES, AND THE JAWS OPENED AS USUAL. ADDITIONAL TISSUE RESECTION WAS NOT REQUIRED AND THERE WAS NO TISSUE DAMAGED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8186591 ↗
• MalfunctionDec 18, 2018Energy Output Problem; Failure to Cut; Energy Output Problem; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DOCTOR TRIED TO CUT TISSUE AFTER SEALING, BUT IT WAS NOT CLEARLY CUT. AND ALSO BLEEDING HAD OCCURRED WHEN THEY OPENED THE JAW. THEY CHANGED THE DEVICE TO A NEW ONE, AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8175931 ↗
• MalfunctionDec 7, 2018Protective Measures Problem; Intermittent Energy Output; Protective Measures Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THE TOTAL PELVIC RESECTION, AT CUTTING PROCESS, THE KNIFE DID NOT MOVE AND IT WAS STUCK WITHOUT ANY MOVEMENT. THE KNIFE, ADVANCED AND WAS EXPOSED, AFTER THAT IT STOPPED. SURGERY WAS COMPLETED BY ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144456 ↗
• MalfunctionAug 20, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN STARTED TO FEEL DIFFERENCE IN THE HANDLE. THE OPENING AND CLOSING OF THE HANDLE WAS STIFF. NEW DEVICE WAS OPENED TO CONTINUE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797115 ↗
• MalfunctionJun 6, 2018Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS PROCEDURE, THE HANDLE OF THE DEVICE DID NOT RETURN SMOOTHLY, AND THE KNIFE ALSO DID NOT RETURN. THE DEVICE WAS RELEASED FROM THE TISSUE BY SQUEEZING THE HANDLE A FEW TIMES. THE ISSUE OCCURRED OCCASIONALLY. THE DEVICE WAS USED UNTIL THE END OF THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7574948 ↗
• MalfunctionApr 25, 2018Overheating of Device; Flare or Flash; Overheating of Device; Flare or Flash

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON AND STAFF BOTH OBSERVED THAT THE DEVICE WAS EXTREMELY HOT TO TOUCH AFTER ACTIVATION. ACCORDINGLY, THEY SAID THAT THE HEAT OF THE JAWS CAUSED TWO SECOND DEGREE BURNS (BLISTERS) ON THE PATIENT¿S RIGHT SIDE OF THE INCISION WITH APPROXIMATELY 1CM IN SIZE EACH. THE DEVICE WAS NOT BEING ACTIVATED AGAINST THE SKIN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 7458692 ↗
• MalfunctionFeb 5, 2018Energy Output To Patient Tissue Incorrect; Difficult or Delayed Activation; Difficult to Open or Close; Energy Output To Patient Tissue Incorrect; Difficult or Delayed Activation; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD AN ACTIVATION ISSUE, WHEREIN THE HANDLE WAS DIFFICULT TO CLOSE TO ACTIVATE SEALING. FOLLOW UP WITH THE REPORTER PROVIDED ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE HANDLE AND THE ACTIVATION BUTTON FOR THE SEALING WOULD BECOME STUCK SOMETIMES AND HANDLE CLOSURE WAS NOT SMOOTH. THE REPORT ALSO INDICATED THAT SEALING WAS INCOMPLETE AT TIMES WHEN ACTIVATING THE DEVICE, SOMETIMES REQUIRING SEVERAL ACTIVATIONS TO ACHIEVE HEMOSTASIS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 7241932 ↗
• MalfunctionDec 27, 2017Defective Device; Defective Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE THE UNIT WAS FAULTY. THE HANDLE DID NOT CLOSE PROPERLY. MANUFACTURER'S VISUAL INSPECTION FOUND THE KNIFE WAS TRAPPED AND PROTRUDING FROM THE JAWS. THE JAWS WOULD NOT OPEN OR CLOSE DUE TO THE PROTRUDING KNIFE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7147693 ↗