N/A LF1923Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327504880), received between Jul 16, 2020 and Jul 3, 2024 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT THE LIGASURE WAS NOT SEALING PROPERLY. ALSO THE TISSUE WAS STICKING TO THE JAWS OF THE DEVICE. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19668249 ↗
• MalfunctionJul 3, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THAT THE LIGASURE WAS NOT SEALING PROPERLY. ALSO THE TISSUE WAS STICKING TO THE JAWS OF THE DEVICE. NO INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19667933 ↗
• MalfunctionJun 21, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE FAILED TO PERFORM AS INTENDED DURING THE CASE. IT WAS REPLACED WITH ANOTHER LIGASURE DEVICE. THERE WAS NO PATIENT INJURY REPORTED, THE EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES, AND THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582288 ↗
• MalfunctionJun 21, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE FAILED TO PERFORM AS INTENDED DURING THE CASE. IT WAS REPLACED WITH ANOTHER LIGASURE DEVICE. THERE WAS NO PATIENT INJURY REPORTED, THE EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES, AND THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582079 ↗
• MalfunctionJun 21, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE FAILED TO PERFORM AS INTENDED DURING THE CASE. IT WAS REPLACED WITH ANOTHER LIGASURE DEVICE. THERE WAS NO PATIENT INJURY REPORTED, THE EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES, AND THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19581733 ↗
• MalfunctionMar 12, 2024Failure to Seal; Failure to Seal

  IT WAS REPORTED THE DEVICE HAD TO BE REPLACED DUE TO THE DEVICE NOT WORKING PROPERLY, EMITTING AN ERROR CODE, AND NOT SEALING TISSUE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888119 ↗
• MalfunctionJan 11, 2024Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  IT WAS REPORTED THE SURGEON WENT TO CLAMP ON, HELD BUTTON, BUT THE DEVICE WOULD NOT SEAL. NO ERROR CODES WERE REPORTED TO HAVE BEEN SEEN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499489 ↗
• MalfunctionJan 11, 2024Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  I WAS REPORTED THE DEVICE SEALED FINE TWICE, BUT WHEN USED THREE MINUTES LATER IT WOULD NOT SEAL THREE TIMES IN A ROW. THERE WAS NO FLUID BUILDUP OR TISSUE REPORTED TO HAVE BEEN PREVENTING THE DEVICE FROM SEALING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499049 ↗
• MalfunctionJan 5, 2024Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE WAS REMOVED FROM THE CASE BECAUSE IT FAILED MULTIPLE TIMES TO COMPLETE CYCLE AND SEEMED TO NOT GET HOT ENOUGH. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18455421 ↗
• InjurySep 17, 2021Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  IT WAS REPORTED THERE WAS CONCERN OVER PATIENT HAVING HEMATOMA 10-24 HOURS POST SURGERY AND CONCERNS AT THAT POINT WITH THE SEALING OF THE DEVICE. NO DEVICE WAS SAVED BECAUSE THE DEVICE WORKED PROPERLY DURING THE CASES. THE PATIENT WAS BROUGHT BACK WITHIN THE SAME DAY FOR EVACUATION OF THE HEMATOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 12492913 ↗
• InjurySep 17, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THERE WAS CONCERN OVER PATIENT HAVING HEMATOMA 10-24 HOURS POST SURGERY AND CONCERNS AT THAT POINT WITH THE SEALING OF THE DEVICE. NO DEVICE WAS SAVED BECAUSE THE DEVICE WORKED PROPERLY DURING THE CASES. THE PATIENT WAS BROUGHT BACK WITHIN THE SAME DAY FOR EVACUATION OF THE HEMATOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 12492912 ↗
• InjurySep 17, 2021Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  IT WAS REPORTED THERE WAS CONCERN OVER PATIENT HAVING HEMATOMA 10-24 HOURS POST SURGERY AND CONCERNS AT THAT POINT WITH THE SEALING OF THE DEVICE. NO DEVICE WAS SAVED BECAUSE THE DEVICE WORKED PROPERLY DURING THE CASES. THE PATIENT WAS BROUGHT BACK WITHIN THE SAME DAY FOR EVACUATION OF THE HEMATOMA. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hematoma

  MAUDE report 12492911 ↗
• MalfunctionJul 16, 2020Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, THE TIP BECAME UNABLE TO OPEN WELL HALFWAY, THE CUTTER BECAME DIFFICULT TO RETURN TO INITIAL POSITION. THEY OPENED A NEW DEVICE BUT THE SITUATION WAS THE SAME. THE THIRD DEVICE WAS ABLE TO BE USED WITHOUT PROBLEM. THE PRODUCT DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10283847 ↗