N/A (REF LF1637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885825017620), received between Nov 22, 2016 and Nov 26, 2019 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Energy Output To Patient Tissue Incorrect” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Accessory Incompatible; Accessory Incompatible

  IT WAS REPORTED THE GENERATOR SAID THE LIGASURE WAS INCOMPATIBLE DURING THE PROCEDURE. THEY TIED OFF VESSEL BY HAND BECAUSE THE DEVICE DID NOT WORK. THEY DID NOT REPLACE THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED AND DELAY WAS 30 MINUTES TO TROUBLESHOOT. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379811 ↗
• MalfunctionJul 29, 2019Device Alarm System; Output Problem

  WHEN USING THE LIGASURE THE HAND PIECE STOPPED WORKING AND THE MACHINE READ THE ERROR: DOES NOT IDENTIFY DEVICE (SOMETHING SIMILAR). DR. STATED THIS HAS HAPPENED BEFORE AND THEY HAD TO SHUT DOWN THE WHOLE MACHINE. A NEW HAND PIECE WAS OPENED AND THE MACHINE WAS SHUT OFF. IT FUNCTIONED PROPERLY AFTER THAT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8835636 ↗
• InjuryMar 20, 2019Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE LIGASURE WASN'T ACHIEVING A SEAL AND THE VESSEL WAS CLOSED FOR APPROXIMATELY 30 SECONDS BUT BURST OPEN. THEY COULD NOT GET A SEAL OR CONTROL THE BLEEDING AND HAD TO GO FROM LAPAROSCOPIC TO OPEN. BLOOD LOSS WAS NOT MEASURED, HOWEVER THE PATIENT DID NOT REQUIRE A TRANSFUSION. ONCE OPEN, THE SURGEON WAS ABLE TO SEE WHERE THE BLEED WAS COMING FROM AND CONTROL THE BLEED AND SEAL THE VESSEL. PATIENT WAS TAKEN TO ICU AFTER THE PROCEDURE TO RECOVER. NO FURTHER FOLLOW UP IS REQUIRED. THE PATIENT HAS A HISTORY OF HYPERTENSION. THE SURGICAL DELAY WAS UNDER AN HOUR. THE LONGER EXPOSURE TO ANESTHESIA DID NOT HAVE ANY EFFECTS ON THE PATIENT. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 8438922 ↗
• InjuryJan 11, 2018Break; Break

  IT WAS REPORTED THE LIGASURE BROKE NEAR THE PROXIMAL END OF THE JAW. THIS OCCURRED WHEN THE SURGEON USED THE DEVICE TO DISSECT FASCIA WITHIN THE BODY. HE CLAMPED THE LIGASURE TO SOME TISSUE AND TRIED TO SEPARATE THE TISSUE BY PULLING DOWN. IT WAS WHEN HE PULLED DOWN IT APPEARED THAT THE "LOCKBOX" PART DISTAL TO THE JAWS BROKE APART. THE PIN WAS LOOSE CAUSING THE FLAT METAL PIECE TO PARTIALLY SEPARATE FROM THE PIN. BOTH PIECES REMAINED ON THE DEVICE WITHIN THE PATIENT AND UPON REMOVAL FROM THE PATIENT. AN X-RAY WAS SHOT TO VERIFY THAT NOTHING WAS RETAINED IN THE PATIENT FROM THE DEVICE. THERE WAS A 4-8 MINUTE DELAY. A NEW DEVICE WAS OPENED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 7184701 ↗
• InjuryNov 16, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  IT WAS REPORTED THE PHYSICIAN FELT THAT THE TIP OF THE LIGASURE DEVICE WAS STICKY DURING USE. TISSUE WAS STICKING TO THE DEVICE AND IT WAS HAVING TROUBLE SEALING TISSUE. THE PHYSICIAN COMPLETED THE CASE WITH THIS DEVICE AND REPORTED IT WORKED FINE AFTER THIS OBSERVATION AND DID NOT HAVE FURTHER ISSUES. POST-OPERATION, THE PATIENT BEGAN BLEEDING IN THE AREA WHERE THEY SEALED AND HAD TO GO BACK TO TREAT AND SEAL THE AREA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT¿S CONDITION WAS STABLE. MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS SPECIFIC EVENT. HOWEVER, NO OTHER INFORMATION WAS PROVIDED FROM THE FACILITY. THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7038124 ↗
• 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 6663534 ↗
• InjuryApr 6, 2017Computer Software Problem; Device Displays Incorrect Message

  IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR A LAP NISSEN. THE PATIENT WAS ANESTHETIZED AND INTUBATED. AN INCISION WAS MADE AND THE TROCAR WAS PLACED. WHEN HOOKING UP THE LIGASURE, THE TRIAD UNIT SIGNALED AN ERROR MESSAGE STATING THE INSTRUMENT WAS NOT RECOGNIZED. THE PROCEDURE WAS STOPPED AND TROUBLESHOOTING WAS PERFORMED ON THE EQUIPMENT. COVIDIEN WAS CALLED TO DETERMINE THE CAUSE OF THE ERROR MESSAGE AND TO SEE IF THE PROBLEM COULD BE FIXED. THEY STATED THE SOFTWARE MUST BE UPDATED BY A COVIDIEN SERVICE PERSON. THE DECISION WAS MADE TO CANCEL THE CASE AND RESCHEDULE THE PATIENT. A SUBSEQUENT PROCEDURE WAS SCHEDULED AND COMPLETED. THE PATIENT HAS MADE A FULL RECOVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6464990 ↗
• InjuryFeb 15, 2017Failure to Cut

  IT WAS REPORTED THAT THE PHYSICIAN TRIED TO USE THE LIGASURE DEVICE AND IT MALFUNCTIONED. THE DEVICE WOULD NOT CUT TISSUE AND CAUSED BLEEDING. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING VOLUME OF BLOOD LOSS AND PATIENT STATUS. NO INFORMATION WAS PROVIDED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 6333182 ↗
• InjuryNov 22, 2016Mechanics Altered

  IT WAS REPORTED THAT THE LIGASURE WAS NOT SEALING PROPERLY. THE PHYSICIAN THEN HAD TO OPEN THE PATIENT TO FINISH THE HYSTERECTOMY, LEADING TO A DELAY IN PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6123239 ↗