LigaSure LS1500Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 30884524000279), received between Apr 20, 2016 and Jun 13, 2024 — classified as 1 death, 11 injuries, 83 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (33 reports).

2 other recalls cover devices cleared under the same FDA submission (K031011); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S INSULATED COVERING WAS PEELED. NONE OF THE PIECE FELL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528836 ↗
• MalfunctionFeb 28, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COLON RESECTION, THE DEVICE¿S JAWS WERE NOT OPENING. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 18803778 ↗
• MalfunctionJul 26, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING BOWEL RESECTION AND MESENTERIC DISSECTION, THE DEVICE HAD NO COAGULATION WHEN THE CLAMP WAS ACTIVATED. THEY USED ANOTHER LIKE LIGASURE DEVICE WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401638 ↗
• MalfunctionApr 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE BUTTON CAME OFF. SO THE DEVICE WAS REPLACED WITH ANOTHER PRODUCT AND WORKED WELL. ONLY THE BUTTON AND PHOTO WERE COLLECTED AND WILL BE SENT.

  Patient problems: Insufficient Information

  MAUDE report 16770343 ↗
• MalfunctionFeb 21, 2023Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT SEAL. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE.

  Patient problems: Insufficient Information

  MAUDE report 16409096 ↗
• MalfunctionJan 11, 2023Energy Output Problem; Difficult to Open or Close; Energy Output Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE JAWS WERE "TEARING TISSUE" WHEN ACTIVATED VIA ENERGY. THERE WAS NO REGRASP ALERT, END TONE WAS HEARD, AND THERE WAS A SIGN OF ENERGY DELIVERY. USED SIMILAR DEVICE AND WORKED SUCCESSFULLY. THE GENERATOR SETTINGS WAS NORMAL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 16141994 ↗
• MalfunctionDec 22, 2022Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE BLADE WOULD NOT DISENGAGE. BRUTE FORCE WAS USED TO OPEN INSTRUMENT AND THE BLADE KEPT GETTING CAUGHT.

  Patient problems: Insufficient Information

  MAUDE report 16040170 ↗
• InjuryNov 14, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE DEVICE LOCKED ON TISSUE. THE DEVICE WAS REMOVED BY CAUTERIZING THE TISSUE TO MOBILIZE THE LIGASURE'S HAND PIECE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15789056 ↗
• MalfunctionOct 25, 2022Retraction Problem; Failure to Cut; Retraction Problem; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVER RESECTION, THE DEVICE COULD BE USED WITHOUT ANY PROBLEMS FOR A WHILE, BUT AFTER REMOVING THE KNIFE FROM AROUND THE 20TH SEAL, THE DEVICE DID NOT CUT ENOUGH, AND THE TRIGGER DID NOT RETURN ANYMORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668433 ↗
• MalfunctionSep 14, 2022Failure to Cut; Difficult to Open or Close; Failure to Cut; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED, THE JAWS WERE NOT OPENING FULLY. THE SURGEON NOTED THAT THE DEVICE WAS NOT CUTTING THE TISSUE PROPERLY AND WAS TEARING" IT INSTEAD."

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

  MAUDE report 15417961 ↗
• MalfunctionSep 12, 2022Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE WHITE RUBBER MATERIAL (INSULATION) ATTACHED TO THE TIP OF THE JAWS (NARROW PART BETWEEN THE TIP AND THE HINGE) WERE PARTIALLY NOT ATTACHED AND PEELING OFF BUT, IT DID NOT FALL INTO THE PATIENT'S ABDOMINAL CAVITY. HOWEVER, THE BROKEN PIECE WAS NOT FOUND. A NEW DEVICE WAS USED AND WORKED AS USUAL.

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

  MAUDE report 15402579 ↗
• MalfunctionMay 15, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE JAWS BECAME UNABLE TO BE OPENED. IT IS UNKNOWN WHETHER THE CAUSE WAS THAT THE LOCK ON THE HANDLE TIP DID NOT RETURN. THE PRODUCT WAS REPLACED WITH A NEW ONE, AND WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14404062 ↗
• MalfunctionApr 11, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE HANDLE OF THE HANDPIECE WAS DIFFICULT TO OPEN AND CLOSE.

  Patient problems: Insufficient Information

  MAUDE report 14079722 ↗
• MalfunctionDec 13, 2021Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD NO SEAL. A NEW HANDPIECE USED WITH THE SAME GENERATOR AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988913 ↗
• MalfunctionOct 20, 2021Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LEFT SALPINGO OOPHORECTOMY, THE DEVICE WAS DIFFICULT TO ACTIVATE BECAUSE THE BUTTON WAS EXTREMELY HARD TO PRESS. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. NOTHING FULLY DISENGAGED FROM THE DEVICE. THERE WAS NO PATIENT INJURY. THE MEDTRONIC INITIAL VISUAL INSPECTION FOUND THE DEVICE'S JAWS WERE BROKEN OFF AND WERE NOT RETURNED. A LIGHT BLUE COLORED WIRE CAN BE SEEN COMING OUT OF THE BROKEN END. ADDITIONALLY, THE DEVICE'S SHAFT WAS BENT NEAR THE BROKEN END AND ITS PLASTIC COATING CAN BE SEEN PEELING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666121 ↗
• MalfunctionAug 25, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE 2 DEVICES' FAILURE WAS DETECTED ONCE THE SURGERY STARTED. WHEN USING IT, THE JAWS DID NOT OPEN. ANOTHER ONE FROM SAME REFERENCE AND LOT NUMBER WAS OPENED AND THE SAME THING HAPPENED, AND THE THIRD THEY OPENED PERFORMED PERFECTLY. THE PATIENT WAS NOT PUT IN RISK AT ANY TIME, SINCE THEY NOTICED THE INCIDENT BEFORE USING IT AND THE TIME TO OPEN AND PLUG THEM WAS DELAYED, NO MORE THAN 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364062 ↗
• MalfunctionAug 24, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE TWO DEVICES' FAILURE WAS DETECTED ONCE THE SURGERY STARTED. WHEN USING IT, THE JAWS DID NOT OPEN. ANOTHER ONE FROM SAME REFERENCE AND LOT NUMBER WAS OPENED AND THE SAME THING HAPPENED, AND THE THIRD THEY OPENED PERFORMED PERFECTLY. THE PATIENT WAS NOT PUT IN RISK AT ANY TIME, SINCE THEY NOTICED THE INCIDENT BEFORE USING IT AND THE TIME TO OPEN AND PLUG THEM WAS DELAYED, NO MORE THAN 10 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359770 ↗
• MalfunctionJul 21, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC NEPHRECTOMY, THE DEVICE HAD A JAW ISSUE WHEREIN IT WAS DIFFICULT OR IMPOSSIBLE TO OPEN. WHILE USING THE DEVICE AT THE START, THEY WERE ABLE TO USE IT WITHOUT ANY PROBLEM UNTIL THE MIDDLE OF THE OPERATION WHERE THE JAWS BECAME UNABLE TO BE OPENED. THE DEVICE WAS NOT BEING APPLIED ON A TISSUE WHEN THE ISSUE HAPPENED. A MEDICAL OR SURGICAL TREATMENT WAS NOT NECESSARY TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THE PATIENT WAS NOT HOSPITALIZED OR DID NOT HAVE PROLONGED HOSPITALIZATION DUE TO THE EVENT. THERE WERE ALSO NO SYMPTOMS OR COMPLICATIONS FROM THE PATIENT RELATED TO THIS EVENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207632 ↗
• MalfunctionJan 12, 2021Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE GRASPING THE LARGE TISSUE AND SEALING THE VAGINAL CUFF, TWO DEVICES CUTTING ACTION WORKED INTERMITTENTLY AND THE TIPS WERE BROKEN OFF AND COMPLETELY DISENGAGE INTO THE PATIENT CAVITY. THE DEVICE¿S TIPS WERE RETRIEVED. NO MEDICAL PROCEDURE NEEDED, NO X-RAY PERFORMED, AND THE PROCEDURE WAS NOT EXTENDED BY MORE THAN 30 MINUTES TO RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155915 ↗
• MalfunctionJan 12, 2021Failure to Cut; Detachment of Device or Device Component; Failure to Cut; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE TOTAL LAPAROSCOPIC HYSTERECTOMY, WHILE GRASPING THE LARGE TISSUE AND SEALING THE VAGINAL CUFF, TWO DEVICES CUTTING ACTION WORKED INTERMITTENTLY AND THE TIPS WERE BROKEN OFF AND COMPLETELY DISENGAGE INTO THE PATIENT CAVITY. THE DEVICE¿S TIPS WERE RETRIEVED. NO MEDICAL PROCEDURE NEEDED, NO X-RAY PERFORMED, AND THE PROCEDURE WAS NOT EXTENDED BY MORE THAN 30 MINUTES TO RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155862 ↗
• MalfunctionDec 5, 2020Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO SEAL. THERE WAS NO ACTIVATION TONE HEARD, THERE WAS NO RE-GRASP ALERT OBSERVED AND THERE WAS NO END TONE HEARD. BOTH LIGASURE DEVICE AND THE ASSOCIATED DEVICE WERE REPLACED AND IT WAS UNKNOWN WHICH CAUSED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS ARE AVAILABLE.

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

  MAUDE report 10950750 ↗
• MalfunctionSep 9, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE JAW BROKE BUT NOTHING FULLY DISENGAGED FROM THE DEVICE. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10509991 ↗
• MalfunctionAug 17, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HAND PIECE STICKS SHUT AND DID NOT OPEN WELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417805 ↗
• MalfunctionAug 5, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAW OF THE DEVICE WAS UNABLE TO OPEN AND COULD NOT BE USED NORMALLY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10370207 ↗
• InjuryJun 19, 2020Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE GOT LOCKED ON TISSUE. THE SURGEON HAD TO CUT AROUND THE JAW TO GET OUT THE TROCAR. THE TISSUE RESECTED WAS VERY THIN AND NO TISSUE DAMAGED. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: Tissue Damage

  MAUDE report 10173652 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031011. One submission often covers many models, so check the product and lot details in each record.

• Z-0640-2012 · Nov 4, 2011 · Terminated
  LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for Valleylab, a division of Tyco Healthcare Group LP, Boulder, CO. Manufactured by
• Z-0641-2012 · Nov 4, 2011 · Terminated
  LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleylab a division of Tyco Healthcare Group LP, Boulder, CO 80301, Manufactured by Cov