LigaSure Atlas LS1020Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 10884524001623), received between Mar 21, 2016 and Sep 17, 2026 — classified as 12 injuries, 130 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (80 reports).

2 other recalls cover devices cleared under the same FDA submission (K010013); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Self-Activation or Keying

  It was reported that, during procedure, the device had activated without the activation button being pushed. Another handpiece was used with the same generator and it worked fine. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798049 ↗
• MalfunctionFeb 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE WITH A USE OF THE LS1020 LIGASURE ATLAS HANDSWITCH 20CM DEVICE, THE JAW WAS DIFFICULT OR IMPOSSIBLE TO OPEN. IT WAS NOT STUCK ON TISSUE. THE DEVICE WAS PLUGGED INTO A GENERATOR AT THE TIME OF THE EVENT. THE DEVICE WAS REPLACED WITH ANOTHER ONE AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431557 ↗
• MalfunctionAug 26, 2025Device Remains Activated; Device Remains Activated

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION SURGERY, THE HANDPIECE BUTTON WAS STUCK IN THE ON POSITION, CONTINUING TO ACTIVATE. A NEW HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22892547 ↗
• MalfunctionJul 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT ABOUT 15 MINUTES OF AN OPEN EXPLORATORY LAPAROTOMY WITH BOWEL RESECTION AND OSTOMY, THE DEVICE¿S JAWS GOT STUCK AND NOT OPENING. SWAPPED OUT FOR A FRESH DEVICE AND THE UNIT PROCEEDED WITHOUT INCIDENT. THE KNIFE BLADE WAS NOT EXTENDED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22601147 ↗
• MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A BILATERAL ADNEXECTOMY, THE JAWS OF THE HANDPIECE CLAMPS BECAME STUCK WHILE BEING USED ON THE PATIENT'S TISSUE. IT WAS NOT STUCK ON TISSUE BUT IT WAS IMPOSSIBLE TO REOPEN THE CLAMP USING THE STANDARD HANDLE. IT WAS CLEANED NORMALLY. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. A NEW CLAMP WAS USED, BUT THE PROBLEM RECURRED. A THIRD HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467503 ↗
• MalfunctionJul 10, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A BILATERAL ADNEXECTOMY, THE JAWS WAS IMPOSSIBLE TO UNCLAMP FROM THE TISSUE USING THE STANDARD HANDLE. IT WAS CLEANED NORMALLY. THE KNIFE BLADE WAS NOT EXTENDED NOR PROTRUDED BEYOND THE EDGE OF THE JAWS. A NEW CLAMP WAS USED, BUT THE PROBLEM RECURRED. A THIRD HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467502 ↗
• MalfunctionJul 7, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BILATERAL ADNEXECTOMY, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN, AND THE JAWS OF THE LIGATURE CLAMP BECAME STUCK WHILE BEING USED ON THE PATIENT'S TISSUE. IT WAS IMPOSSIBLE TO REOPEN THE CLAMP USING THE STANDARD HANDLE. THE DEVICE WAS CLEANED NORMALLY, AND THE KNIFE BLADE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. A NEW CLAMP WAS USED, BUT THE PROBLEM RECURRED WITH THE SECOND DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412858 ↗
• MalfunctionJul 7, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BILATERAL ADNEXECTOMY, THE DEVICE WAS DIFFICULT OR IMPOSSIBLE TO OPEN, AND THE JAWS OF THE LIGATURE CLAMP BECAME STUCK WHILE BEING USED ON THE PATIENT'S TISSUE. IT WAS IMPOSSIBLE TO REOPEN THE CLAMP USING THE STANDARD HANDLE. THE DEVICE WAS CLEANED NORMALLY, AND THE KNIFE BLADE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. A NEW CLAMP WAS USED, BUT THE PROBLEM RECURRED WITH THE SECOND DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412773 ↗
• MalfunctionFeb 18, 2025Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS AN ISSUE WITH TISSUE STICKING TO THE JAWS. THE DEVICE WAS PLUGGED INTO AN FT10 GENERATOR. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THE PHOTO SHOWED THAT THE UPPER JAW OF THE DEVICE HAS SEPARATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402621 ↗
• MalfunctionFeb 13, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, BOTH OF THE HANDLES' TIPS DID NOT OPEN AND ALSO NOT CLOSING. THE DEVICES WERE CLEANED AFTER EACH USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381131 ↗
• MalfunctionDec 9, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING USE, THE JAWS WERE DIFFICULT/IMPOSSIBLE TO OPEN. THE JAWS LOCKED ON THE DEVICE WITH THE FALLOPIAN TUBE IN GRASP. HAD TO PRY JAWS OPEN WITH A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878279 ↗
• MalfunctionOct 8, 2024Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN USING THE UNIT, THE TIP STUCK TO THE TISSUE AND DID NOT COME OFF EASILY. THE DEVICE WAS NOT DIFFICULT TO BE REMOVED. THE PROCEDURE WAS EXTENDED BY ABOUT FIVE MINUTES. THE DEVICE WAS CONNECTED TO THE GENERATOR AND WAS REPLACED BY ANOTHER DEVICE, AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397377 ↗
• MalfunctionSep 3, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING OMENTECTOMY, AT THE BEGINNING OF THE SURGERY, IN OMENTUM, THE DOCTOR WAS PERFORMING THE SEAL AND WHEN OPENING THE JAWS, THE DOCTOR WAS UNABLE TO DO SO AND IT BECAME STUCK. AFTER SEVERAL ATTEMPTS, THE DOCTOR WAS ABLE TO OPEN THEM. THE KNIFE BLADE WAS NOT EXTENDED/EXPOSED AND DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. THIS HAPPENED AGAIN SECOND TIME DURING THE SAME SURGERY AND THE DOCTOR REQUESTED A CHANGE OF INSTRUMENT. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127446 ↗
• MalfunctionJun 27, 2024Energy Output Problem; Intermittent Energy Output; Energy Output Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD NO SEAL (NO EVIDENCE OF ENERGY TRANSFER). DEVICE ENERGY SEALING PROBLEM. THE POWER SUPPLY STOPPED ENERGIZING FROM THE MIDDLE OF THE CASE. THERE WAS NO BLEEDING OCCURRED. GOOD SEALS WERE COMPLETED AT THE BEGINNING OF USE, IT WAS POSSIBLE TO USE IT WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625289 ↗
• MalfunctionMar 14, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING GYNE PROCEDURE, THE DEVICE'S CLAMP WAS BLOCKED WITH INABILITY TO OPEN. DEVICE WAS APPLIED TO THE TISSUE AT THAT TIME. FORCEFULLY OPENED THE JAW OF THE DEVICE, THIS HAPPENED IN THE MIDDLE OF THE PROCEDURE. CHANGED DEVICE IN THE MIDDLE OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 18909563 ↗
• MalfunctionMar 5, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS OPENED AND CHECKED, THE JAWS WERE UNABLE TO OPEN. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18842770 ↗
• MalfunctionMar 5, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A GASTRIC CANCER PROCEDURE, DEVICE INPUT WAS USED TO PERFORM FIRST CUT ON AN OMENTUM VESSEL, BUT CLAMP DOES NOT REOPEN TO CONTINUE CUTTING AND COAGULATING. THE DEVICE WAS REMOVED FROM THE TISSUE USING A CLAMP. THE KNIFE BLADE EXTENDED AND DOES NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. DEVICE WAS NOT CLEANED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837029 ↗
• MalfunctionMar 1, 2024Unintended Power Up; Premature Activation; Communication or Transmission Problem; Unintended Power Up; Premature Activation; Communication or Transmission Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BACK OF THE DEVICE (ACTIVATION BUTTON) WAS LOOSE AND WAS SENSITIVE TO TOUCH AND ACTIVATED ACCIDENTALLY. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822626 ↗
• MalfunctionFeb 29, 2024Smoking; Difficult to Open or Close; Smoking; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHILE PERFORMING GASTRECTOMY, THE EXPERIENCED SURGEON WAS SEALING BIGGER VESSEL. AFTER ONE CYCLE, SURGEON SECOND TIME PRESSING PURPLE CYCLE TO REPEAT THE CYCLE, WITHOUT OPENING THE JAWS (IN THIS HOSPITAL QUITE OFTEN THEY BEHAVE LIKE THIS WITH BIGGER VESSELS). HOWEVER, THIS TIME AFTER SECOND CYCLE WAS COMPLETED, THE SURGEON PRESSED THE KNIFE, THE TISSUE WAS DISSECTED, BUT SURGEON COULD NOT OPEN THE JAWS. TRIED TO OPEN FEW TIMES WITH NO RESULT. AFTER SOME TIME, THEY FELT A SMELL LIKE BURNING PLASTIC FROM THE DEVICE. THEN THEY DECIDE TO PUT THIS LS1020 ON A SIDE AND TOOK ANOTHER ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18812739 ↗
• MalfunctionFeb 27, 2024Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS CONNECTED TO A GENERATOR WITH A SOFTWARE VERSION OF 4.0.4, THE KNIFE BLADE COULD NOT RETRACT AND THE JAWS WERE DIFFICULT OR IMPOSSIBLE TO OPEN, SO THE TISSUE/VESSEL COULD NOT BE RELEASE. AFTER TISSUE SYNTHESIS, THE OPENING OF THE CLAMPS OCCURRED BY FORCING THE DEVICE TO OPEN. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY WITH THIS GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18789741 ↗
• MalfunctionJan 29, 2024Difficult to Open or Close; Separation Problem; Difficult to Open or Close; Separation Problem

  ACCORDING TO REPORTER, DURING EX-LAP PROCEDURE, THE DOCTOR BEGAN HAVING TROUBLE WITH THE DEVICE. THE JAW WAS HAVING TROUBLE OPENING INITIALLY BUT COULD STILL BE OPENED WITH SOME WIGGLING. IT GOT STUCK WHILE ON THE TISSUE AND HAD TO BE PRIED APART WHICH TORE SOME TISSUE THAT WAS NOT NEEDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 18602456 ↗
• MalfunctionJan 22, 2024Device Alarm System; Difficult to Open or Close; Device Alarm System; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING HEMORRHOIDECTOMY, DEVICE CLAMPED DOWN ON THE TISSUE AND THEN WOULD NOT OPEN. THE ERROR MESSAGE THAT CAME UP WAS E402, INCOMPLETE SEAL CYCLE BUT IT WAS WORKING PRIOR TO THIS. THE SURGEON CUT THE DEVICE OUT USING PENCIL CAUTERY THEN SUTURED THE TISSUE CLOSED. ANOTHER LIGASURE DEVICE USED SUCCESSFULLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18552797 ↗
• MalfunctionJan 3, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS UNABLE TO OPEN, THE TISSUE CANNOT BE RELEASED. DEVICE WAS CONNECTED TO THE GENERATOR AND WAS REPLACED BY ANOTHER DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18435697 ↗
• MalfunctionDec 15, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE HANDPIECE WAS DIFFICULT TO CLOSE AND OPEN BUT IT COULD BE PARTIALLY OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340568 ↗
• MalfunctionDec 13, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A COLECTOMY PROCEDURE, THE DEVICE WAS DIFFICULT/IMPOSSIBLE TO OPEN. AFTER CLOSING THE JAWS THEY COULD NOT OPEN AGAIN. THE DEVICE WAS APPLIED TO TISSUE AT THE TIME. NORMALLY, THERE WAS NO TISSUE BETWEEN JAWS, COAGULATION AND CUTTING WORKED FINE. THE DEVICE WAS NOT CLEANED, THE KNIFE BLADE WAS NOT EXTENDED, AND THE KNIFE BLADE DID NOT PROTRUDE BEYOND THE EDGE OF THE JAWS. ANOTHER DEVICE WAS USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010013. One submission often covers many models, so check the product and lot details in each record.

• Z-0773-06 · Jan 27, 2006 · Terminated
  LigaSure Atlas 20 cm Open Procedure Vessel Sealer/Divider
• Z-0772-06 · Jan 27, 2006 · Terminated
  LigaSure Atlas Laparoscopic Vessel Sealer/Divider