N/A (REF LF4318)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885825017880), received between Jan 25, 2017 and Aug 3, 2017 — classified as 11 injuries.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THE LIGASURE HANDPIECES WOULD NOT BURN. TWO LIGASURE DEVICES WERE USED AND THEY BOTH FAILED SO THE DOCTOR HAND TIED THE VESSELS. THE PROCEDURE TOOK ADDITIONAL TIME AS THE VESSELS WERE HAND TIED. THERE WAS UNEXPECTED BLOOD LOSS, BUT THE CUSTOMER DID NOT KNOW THE VOLUME LOST. THERE WAS NO PATIENT INJURY OR ADVERSE CONSEQUENCES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6766056 ↗
• InjuryAug 3, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THE LIGASURE HANDPIECES WOULD NOT BURN. TWO LIGASURE DEVICES WERE USED AND THEY BOTH FAILED SO THE DOCTOR HAND TIED THE VESSELS. THE PROCEDURE TOOK ADDITIONAL TIME AS THE VESSELS WERE HAND TIED. THERE WAS UNEXPECTED BLOOD LOSS, BUT THE CUSTOMER DID NOT KNOW THE VOLUME LOST. THERE WAS NO PATIENT INJURY OR ADVERSE CONSEQUENCES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss; No Known Impact Or Consequence To Patient

  MAUDE report 6766052 ↗
• InjuryJul 28, 2017Charred; Energy Output To Patient Tissue Incorrect; Device Slipped; Sticking; Charred; Energy Output To Patient Tissue Incorrect; Device Slipped; Sticking

  IT WAS REPORTED THAT WHILE CUTTING, THE LIGASURE WOULD STICK, CHAR AND SLIDE IN A NONUNIFORM MANNER. THE DEVICE FAILED TO SEAL SO THE DOCTOR STITCHED THE AREA TOGETHER. NO ISSUES WERE ENCOUNTERED WHILE STITCHING AND THE PATIENT WAS REPORTED TO BE FINE. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS EIGHT MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749688 ↗
• InjuryJul 28, 2017Charred; Energy Output To Patient Tissue Incorrect; Device Slipped; Sticking; Charred; Energy Output To Patient Tissue Incorrect; Device Slipped; Sticking

  IT WAS REPORTED THAT WHILE CUTTING, THE LIGASURE WOULD STICK, CHAR AND SLIDE IN A NONUNIFORM MANNER. THE DEVICE FAILED TO SEAL SO THE DOCTOR STITCHED THE AREA TOGETHER. NO ISSUES WERE ENCOUNTERED WHILE STITCHING AND THE PATIENT WAS REPORTED TO BE FINE. THERE WAS NO PATIENT INJURY AND EXTENDED PROCEDURE TIME REPORTED WAS EIGHT MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6749687 ↗
• InjuryJun 23, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THE LIGASURE WAS NOT SEALING DURING THE PROCEDURE; THE SEALS WERE COMING UNSEALED. THE SEALS WERE ULTIMATELY SUTURED BY HAND. THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6664311 ↗
• InjuryJun 12, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THAT THE LIGASURE DID NOT SEAL AND CAUSED UNEXPECTED BLEEDING, LEADING TO A DELAY TO SWITCH TO AN OPEN SURGERY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 6635852 ↗
• InjuryApr 13, 2017Burst Container or Vessel

  IT WAS REPORTED A LIGASURE WAS USED FOR THE PROCEDURE. HOWEVER, TOWARDS THE END OF THE CASE ONE OF THE SEALS BURST OPEN AND THE PATIENT LOST 500 CC OF BLOOD. NO TRANSFUSION WAS NEEDED. THERE WAS ANOTHER LIGASURE ON HAND, HOWEVER THEY FELT THERE WAS NOT ENOUGH TIME TO SET IT UP SO STITCHING WAS USED TO STOP THE BLEEDING. THE STITCHING WAS SUCCESSFUL IN SEALING. EXTENDED PROCEDURE TIME REPORTED WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 6491672 ↗
• InjuryApr 12, 2017Failure to Cut; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER THE TISSUE WAS GRABBED IN THE JAWS OF THE LIGASURE, THE CAUTERY AND CUT FUNCTION WOULD NOT ACTIVATE. TIME WAS SPENT TROUBLESHOOTING AND MAKING ADDITIONAL ATTEMPTS TO REGRASP THE TISSUE. THE PROCEDURE WAS CHANGED FROM A DELORME PROCEDURE TO AN ALTEMEIER PROCEDURE DUE TO THE INABILITY TO STOP THE BLEEDING. ANOTHER LIGASURE WAS OBTAINED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Damage

  MAUDE report 6488799 ↗
• InjuryJan 30, 2017Device Operates Differently Than Expected

  IT WAS REPORTED "A PATIENT WITH OVARIAN CANCER WAS UNDERGOING AN EXPLORATORY LAPAROTOMY FOR TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, OMENTECTOMY AND DEBULKING WITH POSSIBLE APPENDECTOMY, LYMPH NODE DISSECTION, RECTO-SIGMOID RESECTION AND ANASTOMOSIS. EXAM UNDER ANESTHESIA REVEALED A PELVIC MASS THAT FILLED THE CUL-DE-SAC AND WAS SIDEWALL TO SIDEWALL IN SIZE. PRE-OP CT SCAN SHOWED DISEASE CONSISTENT WITH STATE IIIC WITH AN OMENTAL CAKE, TUMOR ON THE RIGHT DIAPHRAGM, POSSIBLY ON THE SURFACE OF THE RIGHT TIP OF THE LIVER, SMALL PARA-AORTIC NODE AND A LARGE BILATERAL 10-12CM COMPLEX OVARIAN MASSES WITH THE SMALL UTERUS. SURGEON HAD GONE BACK TO THE OBLITERATED UMBILICAL AND IN DISSECTING THE UMBILICAL ARTERY OFF OF THE LATERAL ASPECT OF THE MASS ENCOUNTERED WHAT STARTED OFF TO BE BLEEDING FROM THE UTERINE VEIN OR VEINS THAT CAME OFF OF THE HYPOGASTRIC VEIN. TENTING THE OBLITERATED UMBILICAL LATERALLY AND THE URETER MEDIALLY, SURGEON GRASPED AND ATTEMPTED TO GET CONTROL OF THE BLEEDING. EVERY TIME SURGEON GOT CONTROL, SURGEON FIRED THE LIGASURE AND HEMOSTASIS WAS NOT ADEQUATE. SURGEON HAD USED TWO DIFFERENT LIGASURES IN AN ATTEMPT TO GET HEMOSTASIS AND NEITHER ONE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6288228 ↗
• InjuryJan 30, 2017Improper or Incorrect Procedure or Method; Failure to Form Staple

  IT WAS REPORTED "A PATIENT WITH OVARIAN CANCER WAS UNDERGOING AN EXPLORATORY LAPAROTOMY FOR TOTAL ABDOMINAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, OMENTECTOMY AND DEBULKING WITH POSSIBLE APPENDECTOMY, LYMPH NODE DISSECTION, RECTO-SIGMOID RESECTION AND ANASTOMOSIS. EXAM UNDER ANESTHESIA REVEALED A PELVIC MASS THAT FILLED THE CUL-DE-SAC AND WAS SIDEWALL TO SIDEWALL IN SIZE. PRE-OP CT SCAN SHOWED DISEASE CONSISTENT WITH STATE IIIC WITH AN OMENTAL CAKE, TUMOR ON THE RIGHT DIAPHRAGM, POSSIBLY ON THE SURFACE OF THE RIGHT TIP OF THE LIVER, SMALL PARA-AORTIC NODE AND A LARGE BILATERAL 10-12 CM COMPLEX OVARIAN MASSES WITH THE SMALL UTERUS. SURGEON HAD GONE BACK TO THE OBLITERATED UMBILICAL AND IN DISSECTING THE UMBILICAL ARTERY OFF OF THE LATERAL ASPECT OF THE MASS ENCOUNTERED WHAT STARTED OFF TO BE BLEEDING FROM THE UTERINE VEIN OR VEINS THAT CAME OFF OF THE HYPOGASTRIC VEIN. TENTING THE OBLITERATED UMBILICAL LATERALLY AND THE URETER MEDIALLY, SURGEON GRASPED AND ATTEMPTED TO GET CONTROL OF THE BLEEDING. EVERY TIME SURGEON GOT CONTROL, SURGEON FIRED THE LIGASURE AND HEMOSTASIS WAS NOT ADEQUATE. SURGEON HAD USED TWO DIFFERENT LIGASURES IN AN ATTEMPT TO GET HEMOSTASIS AND NEITHER ONE

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6288137 ↗
• InjuryJan 25, 2017Noise, Audible

  IT WAS REPORTED THAT THE LIGASURE 4318 WAS MAKING A POPPING NOISE DURING THE SEALING PORTION OF THE SURGERY. THE CASE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO PACU WHEN THE PATIENT BEGAN BLEEDING. THE PATIENT WAS TAKEN BACK INTO SURGERY TO RESEAL THE AREA. ANOTHER LIGASURE WAS USED TO RESEAL THE PATIENT. THE SECOND SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS IN STABLE CONDITION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6277498 ↗