LigaSure Advance LF5544Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 10884524002279), received between Jan 22, 2016 and Apr 28, 2022 — classified as 6 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (43 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 121 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE LIGASURE WAS NOT SEALING PROPERLY. THERE WAS AN EVIDENCE OF ANY ENERGY DELIVERY. PATIENT HAD BLEEDING. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. PATIENT WAS BROUGHT BACK SIX DAYS AFTER SURGERY WITH A HEMATOMA.

  Patient problems: Hematoma

  MAUDE report 14233377 ↗
• MalfunctionJan 6, 2020Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ANTERIOR RESECTION, THE INSULATION THAT COVERS THE WIRE TORE RESULTING IN EXPOSED WIRE ON DEVICE JAWS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9551261 ↗
• MalfunctionDec 20, 2019Peeled/Delaminated; Device Damaged Prior to Use; Detachment of Device or Device Component; Peeled/Delaminated; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE'S JAWS STARTED FALLING APART AND THE COATING WAS BURNT OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9505886 ↗
• MalfunctionNov 13, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE'S JAW DID NOT OPEN.

  Patient problems: No Information

  MAUDE report 9318024 ↗
• MalfunctionOct 31, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DIFFICULT TO OPEN AND LOCKED WHEN TESTED. THEY REPLACED THE DEVICE WITH A LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 9263789 ↗
• MalfunctionOct 18, 2019Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS WORKING FINE AT THE START, ADVANCED AT THE SAME TIME AND STOPPED WORKING AND REMAINED LOCKED. IT WAS STUCK AT FIRING POSITION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9207301 ↗
• MalfunctionOct 18, 2019Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS WORKING FINE AT THE START, ADVANCED AT THE SAME TIME AND STOPPED WORKING AND REMAINED LOCKED. IT WAS STUCK AT FIRING POSITION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9207300 ↗
• MalfunctionOct 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A VERTICAL SLEEVE GASTRECTOMY AND HERNIA REPAIR, HALF OF THE PLASTIC PROTECTOR OF THE LIGASURE TIP WAS OFF THE HANDPIECE. THE PIECE WAS VIEWED INSIDE THE PATIENT WITH THE LAPAROSCOPIC CAMERA AND REMOVED.

  Patient problems: No Information

  MAUDE report 9161225 ↗
• InjurySep 30, 2019Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING COLON RESECTION, THE DEVICE WORKED AS INTENDED DURING THE PROCEDURE AND CONSISTENT BURNING OF TISSUE WAS PERFORMED. HOWEVER, THE HANDPIECE WAS CLAMPED ON A VESSEL AND WHEN THE SURGEON TRIED TO OPEN IT, IT WOULD NOT OPEN. TO REMOVE THE DEVICE LAPAROSCOPICALLY, THE SURGEON HAD TO USE A STAPLER TO STAPLE BOTH SIDES OF LIGASURE ADVANCE TO RELEASE THE DEVICE. ANOTHER LIGASURE ADVANCE WAS USED WITHOUT ANY ISSUE DURING THE REST OF THE CASE.

  Patient problems: No Code Available

  MAUDE report 9135975 ↗
• MalfunctionAug 28, 2019Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON INSERTED THE LIGASURE DEVICE THROUGH THE TROCAR AND WHEN THE INSTRUMENT WAS VISIBLE ON THE VIDEO MONITOR, THE SURGEON NOTICED THAT THE 'SLEEVE' ON THE END OF THE SHAFT OF THE DEVICE, LOOKED AS THOUGH IT WAS LOOSE AND ON THE VERGE OF DETACHING FROM THE SHAFT. THEREFORE, HE REMOVED THE INSTRUMENT AND DID NOT USE IT. THE SUTURING DEVICE WAS DIFFICULT TO LOAD. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940429 ↗
• MalfunctionJul 24, 2019Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RIGHT COLECTOMY, THE UNIT FELL APART BUT NOTHING FELL INTO PATIENT'S CAVITY AND IT WAS RETRIEVED. A DIFFERENT PRODUCT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822694 ↗
• MalfunctionJun 11, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, THE DEVICE'S JAWS WERE DIFFICULT OR IMPOSSIBLE TO OPEN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8688477 ↗
• MalfunctionApr 18, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE'S JAW GOT LOCKED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529355 ↗
• MalfunctionApr 11, 2019Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT CUT SUFFICIENTLY. THEY COMPLETED THE CASE WITH A HARMONIC SCALPEL. NO PATIENT INJURY. MEDTRONIC INITIAL INVESTIGATION FOUND THE KNIFE WAS TRAPPED AND CONTAINED WITHIN THE JAWS. THE JAWS WOULD NOT OPEN OR CLOSE DUE TO THE TRAPPED KNIFE. KNIFE TRAP HAPPENS WHEN THE BLADE IS EXTENDED AND THE JAWS ARE NOT COMPLETELY CLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503359 ↗
• MalfunctionDec 27, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, WHEN USING THE LIGASURE THEY HAD TROUBLE OPENING THE JAWS AFTER SEALING AND IT WAS APPLIED TO TISSUE AT THAT TIME. THE SURGEON WAS ABLE TO OPEN THE JAW WITH TIP OF OTHER INSTRUMENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8200030 ↗
• MalfunctionNov 14, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE SURGERY, THE SURGEON SQUEEZED HANDLE AND LIGASURE JAWS WOULD NOT RE-OPEN. NO PATIENT HARM. NO FURTHER INFORMATION REGARDING THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8070422 ↗
• MalfunctionOct 28, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, THE TWEEZER DID NOT CUT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Information

  MAUDE report 8011379 ↗
• MalfunctionAug 21, 2018Flare or Flash; Noise, Audible; Flare or Flash; Noise, Audible

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT WORKING AND THEY HEARD A BANG. A SECOND INSTRUMENT WAS USED, BUT WAS NOT OKAY AS WELL, BECAUSE IT WAS FAULTY AS THE TISSUE WAS BURNED LATERAL. ACCORDING TO THE NURSE WITH ONE OF THE INSTRUMENTS, WHILE IT WAS BEING USED THE INSULATION SLIPPED OFF, WAS REMOVED FROM THE DEVICE, IN A BACKWARD DIRECTION OF THE JAW AND THE SURROUNDING TISSUE WAS BURNED. THE DISENGAGED PART WAS REMOVED FROM THE DEVICE'S TIP AND IT DID NOT FALL INTO THE PATIENT'S CAVITY. LOCALIZED BURN OF LEVEL 1-2 WAS CAUSED BY THE NON-INSULATED PART ON THE JAW. PATIENT IS FINE AND THERE WERE NO OTHER COMPLICATIONS.

  Patient problems: Burn(s); Partial thickness (Second Degree) Burn

  MAUDE report 7802578 ↗
• MalfunctionJul 31, 2018Mechanical Problem; Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN. SURGEON REPLACED IT WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735018 ↗
• MalfunctionJul 27, 2018Entrapment of Device; Mechanical Jam; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAWS CLOSED ON AND LOCKED ON THE TISSUE DURING THE SEAL CYCLE. THE SURGICAL TECHNICIAN REPORTED THAT THE SURGEON MAY HAVE TRIED TO CUT THROUGH A STAPLE LINE WITH THE DEVICE JUST PRIOR TO ISSUE. OPENED ANOTHER LIGASURE AND THE NEW LIGASURE HANDLE WAS USED TO TRANSECT NEXT TO CLOSED JAWS, AND COMPLETED THE PROCEDURE. NO PATIENT HARM AND NO SIGNIFICANT TISSUE LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7727151 ↗
• MalfunctionJul 12, 2018Material Frayed; Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD FRAYS NEAR THE JAW. NO FULL DETACHMENT FROM THE INSTRUMENT; THUS NO DEVICE REMNANT IN THE ABDOMINAL CAVITY. THE REPLACED FOR A LIKE DEVICE TO COMPLETE THE PROCEDURE.THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7681280 ↗
• MalfunctionMay 24, 2018Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, SCRUB NURSE WAS ABLE TO SLIDE THE PLASTIC SHEATH BELOW THE TIP UP AFTER THE CASE TO EXPOSE THE WIRES, IT WASN'T HAPPENING DURING THE CASE. THIS WAS THE SECOND DEVICE USED IN THE CASE.

  Patient problems: No Patient Involvement

  MAUDE report 7541320 ↗
• MalfunctionMay 21, 2018Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PLASTIC SHEATH OF THE DEVICE BELOW THE TIP SLIDES UP AND IT EXPOSED THE METAL UNDERNEATH. THEY WERE CONCERNED THAT THE EXPOSED METAL WOULD BURN THE SURROUNDING TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7529904 ↗
• MalfunctionApr 24, 2018Break; Detachment Of Device Component; Mechanical Problem; Failure to Cut; Difficult to Open or Close; Break; Detachment Of Device Component; Mechanical Problem; Failure to Cut; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING SACROCOLPOPEXY, DEVICE'S BLADE TIP BROKE OFF AND WOULD NOT CUT. NOTHING FELL INTO PATIENT'S CAVITY. THE BLADE WAS STUCK IN SOME WAY AND WOULD NOT OPEN ANYMORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455799 ↗
• MalfunctionApr 19, 2018Energy Output To Patient Tissue Incorrect; Adverse Event Without Identified Device or Use Problem; Energy Output To Patient Tissue Incorrect; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO ACTIVATE AND CLAMP SEALING WAS NOT OPTIMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7445286 ↗