N/A LF1737Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07613327375817), received between Jan 2, 2020 and Nov 6, 2020 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (17 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE STOPPED WORKING. AN ERROR MESSAGE POPPED UP ABOUT AN INCOMPLETE SEAL CYCLE EVEN THOUGH SURGEON HAD STOPPED THE CYCLE ITSELF. THERE WAS NO PATIENT HARM AND NO EXCESSIVE PATIENT BLEEDING. 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 10800817 ↗
• MalfunctionOct 13, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE KEPT GIVING AN ERROR CODE ON THE GENERATOR STATING THERE WAS NOT ENOUGH TISSUE IN THE JAWS. THE JAWS WERE OPENED AND CLOSED MULTIPLE TIMES WITHOUT RESOLUTION. 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 10673903 ↗
• MalfunctionSep 29, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE MARYLAND JAW USED TO REMOVE THE APPENDIX MALFUNCTIONED AND WAS NOT WORKING PROPERLY. 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 10603567 ↗
• MalfunctionSep 9, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE HAD AN UNKNOWN FAILURE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10507982 ↗
• MalfunctionSep 9, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE HAD AN INCOMPLETE CYCLE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507932 ↗
• MalfunctionAug 27, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE PRODUCT FAILED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10459667 ↗
• MalfunctionAug 12, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE WOULD NOT WORK. THEY TRIED UNPLUGGING THE DEVICE AND IT WOULD STILL NOT FUNCTION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. HOWEVER, THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10399075 ↗
• MalfunctionJun 10, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE DIDN'T WORK. THERE WAS NO RESPONSE WHEN THE DEVICE WAS CONNECTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT A FEW MOMENTS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10141266 ↗
• MalfunctionJun 5, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE WASN'T SEALING WELL AND KEPT ALARMING DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123761 ↗
• MalfunctionJun 4, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SURGEON TRIED TO FIRE THE LIGASURE DEVICE. THE DEVICE FAILED TO FIRE AND A GENERATOR ERROR CODE OCCURRED. THE DEVICE WAS IMMEDIATELY REMOVED AND A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121787 ↗
• MalfunctionJun 4, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE WAS NOT ABLE TO COAGULATE TISSUE. IT WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THERE WAS NO UNEXPECTED PATIENT BLEEDING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10121785 ↗
• InjuryMay 28, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. EXCESSIVE BLEEDING WAS SEEN. THE COMPLAINANT IS NOT AWARE OF THE VOLUME OF BLOOD LOSS. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 10099410 ↗
• MalfunctionMay 26, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE MARYLAND JAW LIGASURE. THEY USED MULTIPLE DEVICES BECAUSE OF AN INCOMPLETE SEAL CYCLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 5 - 10 MINUTES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE COMPLAINANT. THE COMPLAINANT WAS UNABLE TO PROVIDE SPECIFIC EVENT DETAILS. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10088124 ↗
• MalfunctionApr 30, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE HAND-PIECE APPEARED TO BE RUNNING A CYCLE BUT IT WAS NOT ACTUALLY BURNING. THE GENERATOR PERIODICALLY GAVE A MESSAGE TO RE-GRASP TISSUE, BUT THE LIGASURE HAND-PIECE STILL DID NOT WORK AND THE JAWS APPEARED TO BE LOOSE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THERE WAS NO UNEXPECTED BLEEDING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014265 ↗
• MalfunctionApr 27, 2020Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE LIGASURE DEVICE WOULD NOT CUT DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE REPORTED EXTENDED PROCEDURE TIME WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003394 ↗
• MalfunctionApr 2, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD A MISFIRE ON A LIGASURE. THE DEVICE WOULD NOT FIRE. THERE WAS NO PATIENT INJURY. THE COMPLAINANT IS NOT AWARE OF ANY MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9919067 ↗
• MalfunctionMar 31, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LIGASURE PRODUCED AN ERROR MESSAGE AFTER AN HOUR OF USE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908769 ↗
• MalfunctionMar 31, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE STOPPED PUTTING ENERGY THROUGH THE JAWS DURING THE CASE AND KEPT POPULATING ERROR CODE 403. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS 2 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908707 ↗
• MalfunctionMar 30, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE HANDPIECE MALFUNCTIONED MULTIPLE TIMES DURING THE PROCEDURE AND THE SURGEON FELT THE DEVICE DID NOT PROPERLY SEAL. THERE WAS NO PATIENT INJURY AND THE EXTENDED PROCEDURE TIME REPORTED WAS APPROXIMATELY 5 MINUTES. THERE WAS NO UNEXPECTED BLEEDING. THE COMPLAINANT IS NOT AWARE OF ANY UNANTICIPATED MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9901726 ↗
• MalfunctionMar 26, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THERE WAS A LIGASURE PRODUCT MALFUNCTION DURING THE LAPAROSCOPIC HEMICOLECTOMY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT A FEW MINUTES TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9887110 ↗
• MalfunctionMar 25, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT HALFWAY THROUGH THE CASE, THE LIGASURE DEVICE STOPPED SEALING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 5 MINUTES. THERE WAS NO UNEXPECTED PATIENT BLEEDING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881450 ↗
• MalfunctionMar 25, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THERE WAS A LIGASURE INSTRUMENT DEFECT DURING A HIATAL HERNIA REPAIR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879133 ↗
• MalfunctionMar 23, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE WAS NOT SEALING PROPERLY. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9867895 ↗
• MalfunctionMar 18, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE DEVICE FUNCTIONED AT BEGINNING OF CASE, AND DURING THE CASE IT CEASED FUNCTIONING. MULTIPLE TRIES WERE MADE TO GET IT TO FUNCTION. THE HAND PIECE WAS CLEANED AND UNPLUGGED TO NO AVAIL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL TO REPLACE THE DEVICE. THE CASE WAS COMPLETED WITH NO ADVERSE INCIDENT AND NO TRANSFUSION WAS REQUIRED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9851139 ↗
• MalfunctionMar 18, 2020Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT HALFWAY THROUGH THE CASE, THE LIGASURE DEVICE STOPPED SEALING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL AT 5 MINUTES. THERE WAS NO UNEXPECTED PATIENT BLEEDING. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850861 ↗