LigaSure LF1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10884521125520), received between Feb 9, 2016 and Nov 26, 2019 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K092879); they may or may not involve this specific model.

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A COLON PROCEDURE, THE HANDLE BECAME STIFF AND THE JAWS BECAME UNABLE TO BE RELEASED AFTER SEALING. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379687 ↗
• MalfunctionAug 6, 2019Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING TOTAL GASTRECTOMY/ ROUX-EN-Y(R-Y) SURGERY, AFTER USING ABOUT AN HOUR, THE DOCTOR SUDDENLY REPORTED THAT THE HANDLE DID NOT RETURN TO THE INITIAL POSITION AND THE FINGERS GOT HURT BY SQUEEZING. THE FEELING OF SQUEEZE WAS OBVIOUSLY DIFFERENT THAN USUAL, AND THE RETURN OF THE HANDLE TO BE BAD. IT WAS AN IMPRESSION THAT THE PRODUCT DID NOT NEED TO REPLACE WITH A NEW ONE BUT COULD ENDURE TO BE USED. AFTER TOUCHING THE PRODUCT IN AN UNCLEAN FIELD, THE SALES REP WHO ATTENDED THE OPERATION HAD AN IMPRESSION THAT THE TRIGGER WAS STIFF LIKE SLIGHTLY BEING CAUGHT WHEN PULLED THE TRIGGER, AND AFTER OPERATING IT SEVERAL TIMES, THE HANDLE RETURNED TO THE ORIGINAL POSITION. BUT THE HANDLE DID INDEED APPEAR TO HAVE NOT RETURNED AGAIN COMPLETELY TO THE NEUTRAL POSITION AFTER FULL STROKE. THE PRODUCT DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. SURGICAL TIME WAS NOT EXTENDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865864 ↗
• MalfunctionJul 23, 2019Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING DISTAL GASTRECTOMY, THE KNIFE WAS UNABLE TO RETURN IN THE OPERATION. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THE PRODUCT DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8819764 ↗
• MalfunctionJun 11, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE JAWS WERE NOT ABLE TO BE OPENED. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE, BUT NO TISSUE DAMAGE WAS CAUSED AND THE SURGERY WAS EXTENDED BY LESS THAN 30 MINUTES. REPLACED BY A NEW PRODUCT AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689838 ↗
• MalfunctionApr 11, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING NEPHRECTOMY, THE SEALING COULD NOT BE PERFORMED AS USUAL FROM THE START, AND OOZING OCCURRED FREQUENTLY. THE GENERATOR AND HANDPIECE WERE REPLACED WITH ANOTHER, AND THE SITUATION SLIGHTLY IMPROVED AND THE OPERATION WAS CONTINUED TILL THE END. NO PATIENT HARM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8503572 ↗
• MalfunctionMar 14, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING OPEN COLON RESECTION, AN END TONE WAS HEARD BUT WHEN THE SURGEON OPENED THE JAWS OOZING BLEEDING OCCURRED REPEATEDLY AMOUNTING TO LESS THAN 50CC. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422147 ↗
• MalfunctionMar 13, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING ESOPHAGECTOMY/GASTRIC TUBE PROCEDURE, IN THE MIDDLE OF PROCEDURE ABOUT AT THE TENTH SEALING, THE DEVICE SEALING BECAME INSUFFICIENT OR HALF CAUTERIZED AND IT HAS END TONE. THERE WAS NO BLEEDING OCCURRED. REPLACED WITH NEW SIMILAR DEVICE AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417642 ↗
• MalfunctionFeb 18, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING CYSTOPROSTATECTOMY, THE DEVICE WAS ABLE TO ACTIVATE NORMALLY AND PRODUCED END TONE, BUT THE PHYSICIAN COULD NOT STOP BLEEDING. HEMOSTASIS WAS PERFORMED AS THE FOLLOWING STEPS: THE USE OF THE DEVICE TO STOP BLEEDING AND WHEN HEMOSTASIS FAILED, THEY USED A DIFFERENT DEVICE TO STOP BLEEDING, BUT FAILED TO STOPPED BLEEDING EITHER, UNIT THEY USED THE METHOD OF SOFT COAGULATION. ALSO, THE ACTIVATION SETTING WAS CHANGED TO BAR 3 FROM BAR 2, HOWEVER, THE METHOD DID NOT HAVE EFFECT. BLOOD TRANSFUSION WAS DONE TO PATIENT AT THE END OF THE PROCEDURE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8347706 ↗
• MalfunctionFeb 1, 2019Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A NEPHRECTOMY, THE JAWS COULD NOT OPEN AFTER THE SEALING WAS COMPLETED. THE DEVICE WAS REMOVED FROM THE TISSUE BY ADDITIONALLY RESECTING THE TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS AN END TONE HEARD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297200 ↗
• MalfunctionSep 11, 2018Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, THE TISSUE STUCK ON JAW. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7866378 ↗
• MalfunctionSep 5, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO SEALING DURING SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846502 ↗
• MalfunctionJul 3, 2018Dull, Blunt; Device Displays Incorrect Message

  SURGEON REQUESTED LIGASURE IMPACT INSTRUMENT TO BE USED. INSTRUMENT WAS NOT AVAILABLE. SURGEON DECIDED TO USE LIGASURE BLUNT TIP DEVICE. WHEN DEVICE WAS PLUGGED INTO MACHINE, AN ALARM CAME ON THAT SAID "INVALID". ANOTHER LIGASURE BLUNT TIP DEVICE OPENED WITH SAME MESSAGE. MACHINE WAS SWITCHED BUT ALSO HAD THE SAME MESSAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658464 ↗
• MalfunctionMay 10, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, DURING COLECTOMY END TO END ANASTOMOSIS, THE DEVICE WORKED FINE IN THE BEGINNING BUT 4 HOURS LATER, TISSUE WAS NOT SEALED. AN END TONE WAS HEARD, THERE WAS NO BLEEDING. THE DEVICE WAS DISCONNECTED FROM THE GENERATOR AND CONNECTED AGAIN, BUT THE ISSUE WAS NOT SOLVED. NEW LIGASURE WAS OPENED AND IT WORKED FINE. THE REMOVED HANDPIECE WAS CHECKED, AND THE HANDLE, TRIGGER, WORKED FINE AND NO ABNORMALITY WAS OBSERVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503698 ↗
• MalfunctionMar 20, 2018Device Displays Incorrect Message; Difficult to Open or Close; Device Displays Incorrect Message; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER A SHORT TIME OF USE THE RACK WAS LOCKED AND DID NOT ALLOW TO CONTINUE CUTTING OR DID NOT OPEN THE "BLADES". THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7352786 ↗
• MalfunctionMar 8, 2018Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING NEPHRECTOMY, THE DEVICE WORKED FINE IN THE BEGINNING BUT THEN THE JAWS GOT LOCKED ONTO TISSUE AND DID NOT OPEN. THE JAWS WERE SOMEHOW FORCIBLY OPENED AND RELEASED FROM TISSUE, BUT THEN THE JAWS DID NOT OPEN AND CLOSE SMOOTHLY. NEW DEVICE WAS USED TO CONTINUE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323401 ↗
• MalfunctionJan 29, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT'S ACTIVATION BUTTON WAS SEPARATE FROM THE CLAMP AND WAS LOOSE INSIDE THE STERILE PACKAGING. IT IS REPLACED BY ANOTHER OF THE SAME MODEL. THE PATIENT WAS HAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7226199 ↗
• MalfunctionJan 9, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT SEAL. IT IS UNKNOWN IF THERE WAS A REGRASP ALARM OR AN END TONE. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 7176333 ↗
• MalfunctionJan 2, 2018Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE JAWS DID NOT OPEN AFTER MAKING FOUR SEALS. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE WITHOUT ANY PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159107 ↗
• MalfunctionSep 6, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE DEVICE DID NOT SEAL TISSUE. THE DEVICE ACTIVATED AND AN END TONE WAS HEARD INDICATING A COMPLETED SEALING CYCLE. THERE WAS NO PATIENT INJURY, AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6845304 ↗
• MalfunctionAug 16, 2017Entrapment of Device; Entrapment of Device

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE JAWS OF THE DEVICE DID NOT OPEN AFTER SEALING. THE JAWS WERE OPENED MANUALLY, RESULTING IN UNDER 200CC OF BLOOD LOSS. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6799411 ↗
• MalfunctionAug 2, 2017Energy Output To Patient Tissue Incorrect; Sticking; Energy Output To Patient Tissue Incorrect; Sticking

  THE CUSTOMER REPORTED THAT DURING PROCEDURE, THE DEVICE DID NOT SEAL TISSUE PROPERLY FROM THE BEGINNING OF USE. THE DEVICE WAS ACTIVATED BUT THE THERMAL SPREAD DID NOT SEEM TO BE ENOUGH. TISSUE WOULD ALSO STICK TO THE JAWS, AND THE JAWS WERE DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY, AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762098 ↗
• MalfunctionFeb 9, 2016Detachment Of Device Component; Component Falling

  THE CUSTOMER REPORTED THAT THE ACTIVATION BUTTON FELL OFF OF THE DEVICE PRIOR TO USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5420554 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092879. One submission often covers many models, so check the product and lot details in each record.

• Z-0954-2011 · Dec 8, 2010 · Terminated
  Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boul