LigaSure LS1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10884524002187), received between Dec 20, 2016 and Aug 13, 2024 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (24 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 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Difficult to Open or Close; Intermittent Energy Output; Difficult to Open or Close; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING USE, THE HANDPIECE JAMMED HALFWAY THROUGH THE CASE. THE JAWS WOULD NOT OPEN.

  Patient problems: Insufficient Information

  MAUDE report 19973142 ↗
• MalfunctionMay 3, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAW WAS DIFFICULT TO OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16864960 ↗
• MalfunctionMar 3, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AN ABNORMAL CLINK SOUND WAS HEARD BEFORE USE, BUT IT WAS USED AS IS. DURING THE PROCEDURE, SEALING WAS PERFORMED SEVERAL TIMES. AFTER CLAMPING AND SEALING THE THICK TISSUE AT THE END OF THE SURGERY, THE RATCHET FAILED TO COME OFF. ADDITIONAL DISSECTION WAS PERFORMED ON THE CLAMPED TISSUE IN ORDER TO REMOVE IT. AFTERWARDS, A NEW HANDPIECE WAS OPENED TO COMPLETE THE SURGERY. AFTER THE SURGERY, THE HANDPIECE WHERE THE RATCHET DID NOT OPEN WAS CHECKED AGAIN, AND IT OPENED WITHOUT ANY PROBLEM.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 16479034 ↗
• MalfunctionJan 20, 2023Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, DEVICE JAW HAD TISSUE ADHESION PROBLEMS. SOMETHING WAS STUCK AND IT COULD NO LONGER BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215918 ↗
• MalfunctionFeb 16, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS USED FOR PARTIAL BREAST DISSECTION. BLEEDING WAS OBSERVED SEVERAL TIMES AFTER THE SEAL DURING INTRAOPERATIVE ADIPOSE TISSUE DISSECTION. THE BLEEDING AREA WAS RE-SEALED AND RECOVERED. THERE WAS REGRASP ALERT, END TONE WAS HEARD AND EVIDENCE OF ACTIVATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542835 ↗
• MalfunctionMay 17, 2021Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE LIGASURE TIP WAS JAMMING ON TISSUE DURING USAGE. IT WAS VERY STIFF ON OPENING AND A PIECE BROKE OFF DURING REMOVAL FROM TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831992 ↗
• MalfunctionMar 2, 2021Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE BLADE GOT STUCK AGAIN AND AGAIN. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398168 ↗
• MalfunctionSep 1, 2020Retraction Problem; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S KNIFE BLADE DID NOT RETRACT. ANOTHER LIGASURE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10475749 ↗
• MalfunctionAug 17, 2020Mechanical Problem; Retraction Problem; Failure to Cut; Mechanical Problem; Retraction Problem; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE WAS NOT CUTTING AS BLADE WAS STICKING WHEN ADVANCING OR RETRACTING. A NEW HANDPIECE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10412727 ↗
• MalfunctionMay 27, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HAND PIECE JAW'S WAS DIFFICULT/IMPOSSIBLE TO OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10092250 ↗
• MalfunctionApr 2, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE THORACO/LOBECTOMY PROCEDURE IN ORDER TO REMOVE THE ADHESION OF THE LUNG, WHEN THE SEALING WAS ACTIVATED AND PULLED THE TRIGGER TO ADVANCE THE KNIFE, THE TRIGGER DID NOT RETURN TO ITS ORIGINAL POSITION, AND THE KNIFE REMAINED BEING OUT. AFTER THAT, THEY PULLED THE TRIGGER SEVERAL TIMES IN ORDER TO RETURN THE KNIFE, BUT IT DID NOT RETURN. THEREFORE, A NEW DEVICE WAS OPENED AND USED, AND THERE WAS NO PROBLEM WITH THAT. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES, NO RESECTION REQUIRED. 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 9917321 ↗
• MalfunctionMar 20, 2020Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE WAS DIFFICULT/IMPOSSIBLE TO OPEN WHEREIN THE JAWS LOCKED ON TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9860577 ↗
• MalfunctionOct 23, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING WHIPPLE PROCEDURE, THE DEVICE WAS NOT COAGULATING PROPERLY. THEY REPLACE THE DEVICE WITH A LIKE DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226202 ↗
• MalfunctionOct 14, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, AFTER 20 MINUTES OF ESOPHAGECTOMY PROCEDURE, THE DEVICE WOULD NOT OPEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9183977 ↗
• MalfunctionJul 10, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING AN ESOPHAGECTOMY, AFTER 20 MINS OF USED, THE JAWS OF THE DEVICE WOULD NOT OPEN. IT WAS REMOVED AND ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8775721 ↗
• MalfunctionApr 10, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN INCOMPLETE SEAL. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501814 ↗
• MalfunctionApr 1, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE NEPHRECTOMY, THE JAWS OF THE DEVICE WOULD NOT OPEN, AND THE DEVICE COULD NOT CUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PRODUCT DID NOT LOCK ON TISSUE AND WAS REMOVED FROM THE TISSUE WITHOUT DAMAGING IT. ADDITIONAL TISSUE RESECTION WAS NOT REQUIRED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8468965 ↗
• MalfunctionSep 12, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE TIP OF THE DEVICE WOULD NOT OPEN PROPERLY AFTER 3 FIRINGS. IT OCCURRED AFTER 3-5 MINS OF BEING USED. A SECOND DEVICE WAS REQUIRED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7870329 ↗
• MalfunctionMay 21, 2018Retraction Problem; Difficult to Open or Close; Retraction Problem; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY PROCEDURE, TISSUE WAS SEALED FINELY AS USUAL, BUT THEN THE KNIFE DID NOT RETURN AND THE DEVICE COULD NOT BE USED ANYMORE. A NEW DEVICE WAS OPENED TO CONTINUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530677 ↗
• MalfunctionApr 24, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON DID NOT BELIEVE THEY WERE GETTING THE ADEQUATE TISSUE EFFECT AS THEY EXPERIENCED SOME OOZING OF BLOOD FROM TISSUE AFTER SOME SEALS. THERE WAS AN END TONE HEARD AND AN EVIDENCE OF ENERGY DELIVERY WAS PRESENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7455466 ↗
• MalfunctionApr 24, 2018Device Stops Intermittently; Difficult to Open or Close; Device Stops Intermittently; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE¿S JAWS CLOSED AND COULD NOT ACTIVATE OR OPEN WHILE BEING APPLIED TO TISSUE. THE JAWS EVENTUALLY OPENED AND THEY GRABBED A NEW INSTRUMENT. THERE WAS NO PATIENT INJURY OR BLOOD LOSS.

  Patient problems: No Information

  MAUDE report 7454647 ↗
• MalfunctionMar 8, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDLE WAS STIFF. THE SURGEON HAD DIFFICULT TIME TO LATCH AND UNLATCH THE HANDLE. NEW DEVICE WAS USED TO CONTINUE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323876 ↗
• MalfunctionFeb 15, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD A COMPONENT ISSUE AND WAS DIFFICULT TO ACTIVATE, WHEREIN THE SEALING ACTIVATOR BUTTON COVER (VIOLET COLOR) DETACHED FROM THE SEALING DEVICE. IT WAS POSSIBLE TO CONTINUE AND COMPLETE THE PROCEDURE BECAUSE THE SURGEON WAS ABLE TO ACTIVATE THE SEALER, BUT WAS MORE DIFFICULT BECAUSE THE CAP FELL APART DURING THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7274008 ↗
• MalfunctionDec 28, 2017Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE JAWS DID NOT OPEN AFTER SEALING. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151188 ↗
• MalfunctionDec 12, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE WAS OPENED FOR A RIGHT LOBECTOMY, CHOLECYSTECTOMY, WEDGE RESECTION OF DIAPHRAGM, IVC RESECTION PROCEDURE BUT IT WAS NOT USED IN SURGERY BECAUSE THE PURPLE ACTIVATION BUTTON HAD BROKEN OFF. ANOTHER INSTRUMENT WAS OPENED AND USED IN SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108132 ↗

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-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
• 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