N/A LF1944Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07613327504903), received between Aug 6, 2021 and Jun 13, 2025 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT THE DEVICE WAS NOT FIRING. AS REPORTED, WHEN THE COMPLAINANT DISCUSSED THE EVENT WITH THE OR MANAGER, IT WAS USER ERROR AS THE GENERATOR WAS SWITCHED TO THE 'ON' FUNCTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS JUST A COUPLE MINUTES TO OPEN ANOTHER DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204443 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE COMPLAINT DEVICE HAD A 'WOULD NOT SEAL' ERROR CODE. THE COMPLAINT DEVICE WAS REPLACED AND THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES JUST TO SWITCH DEVICES OUT. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397120 ↗
• MalfunctionMay 24, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED, "DEVICE WORKING FINE IN THE FIRST 90 MINUTES OF CASE. DURING THIS TIME, INITIALLY THE DOCTOR WAS USING THE COMPLAINT DEVICE BUT ERROR CODE FOR "INCOMPLETE SEAL" KEPT ALARMING ON GENERATOR BECAUSE HE WAS PRE-MATURELY TAKING FINGER OFF ACTIVATION BUTTON BEFORE SEALING WAS COMPLETE. AS THE CASE WENT ON, LIGASURE STOPPED SEALING ALL TOGETHER. WE CHECKED FOR STAPLES IN THE TISSUE AREA (FOUND NONE) AND WIPED JAWS OF DEVICE OFF BUT THIS DID NOT RESOLVE ISSUE. HAD TO OPEN ANOTHER REPROCESSED LIGASURE." THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 2 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397111 ↗
• MalfunctionMay 24, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE COMPLAINT DEVICE DID NOT COMPLETE THE CUTTING/CAUTERIZING CYCLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19396588 ↗
• MalfunctionMar 18, 2024Output Problem; Output Problem

  IT WAS REPORTED THE DEVICE HAD TO BE REPLACED DUE TO THE DEVICE INITIALLY WORKING, STOPPING, AND THEN SHOWING AN ERROR CODE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL, ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926643 ↗
• MalfunctionMar 18, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE HAD TO BE REPLACED DUE TO THE DEVICE INITIALLY WORKING, STOPPING, AND THEN SHOWING AN ERROR CODE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL, ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926641 ↗
• MalfunctionMar 8, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE WAS NOT WORKING PROPERLY AS IT MADE A CLICKING SOUND BUT WOULD NOT FULLY ENGAGE TISSUE TO FUNCTION ADEQUATELY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS FIVE MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869476 ↗
• MalfunctionFeb 20, 2024

  SURGEON INSERTED A REPROCESSED MARYLAND LIGASURE REF#LF1944. HE BEGAN USING THE DEVICE, AND IT ONLY WORKED TWO TIMES BEFORE IT STOPPED AND AN ERROR MESSAGE WAS SHOWN ON THE BOVIE MACHINE. WE TRIED TO UNPLUG IT AND RE-PLUG IN THE LIGASURE BUT IT WOULD NOT WORK AND CONTINUED TO SHOW THE ERROR MESSAGE. I OPENED AN ADDITIONAL REPROCESSED LIGASURE REF# LF1944. THE SURGEON REPEATED THE PROCESS AND IT ALSO WORKED ONE TIME AND THEN GAVE AN ERROR MESSAGE. NO HARM WAS DONE TO THE PATIENT AS THE DEVICE JUST STOPPED WORKING. BOTH DEVICES WERE SAVED AND PLACED BACK INTO THEIR ORIGINAL BOXES, AND THE BOXED LABELED AND PLACED IN RED BIOHAZARD BAGS. THE DEVICES BOTH HAD THE SAME LOT NUMBER AND WERE TURNED INTO OUR MATERIALS MANAGER. THE MATERIALS MANAGER PULLED ALL OF THE REPROCESSED MARYLAND LIGASURE DEVICES THAT HAD THE SAME LOT NUMBER AS THE DEFECTIVE ONES.

  Patient problems: Insufficient Information

  MAUDE report 18738590 ↗
• MalfunctionFeb 1, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE HAD INCOMPLETE CYCLES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627948 ↗
• MalfunctionFeb 1, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE HAD INCOMPLETE CYCLES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627245 ↗
• MalfunctionFeb 1, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE WOULD NOT SEAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18627243 ↗
• InjuryAug 17, 2023Energy Output Problem; Use of Device Problem; Energy Output Problem; Use of Device Problem

  IT WAS REPORTED THE DEVICE FAILED TO SEAL, THERE WAS EXTRA BLOOD LOSS, AND THAT A SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO TRANSFUSION AND NO OTHER MEDICAL INTERVENTION REPORTED. THE REPORTED EXTENDED PROCEDURE TIME WAS TWO HOURS AND THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED SUCCESSFULLY. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17568188 ↗
• MalfunctionMay 17, 2022Misfire

  LAPAROSCOPIC LIGASURE¿ MARYLAND JAW DEVICE, REPROCESSED BY STRYKER #1944, MISFIRED AND DID NOT COMPLETELY SEAL.

  Patient problems: Failure to Anastomose

  MAUDE report 14418221 ↗
• MalfunctionFeb 28, 2022Mechanical Problem

  LIGASURE MARYLAND JAW WAS IN USE AND WOULD NOT SEAL. NO HARM WAS DONE TO THE PATIENT. LIGASURE WAS REMOVED FROM THE FIELD IMMEDIATELY AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618565 ↗
• MalfunctionJan 5, 2022Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT THE DEVICE FUNCTIONED INTERMITTENTLY AND A MACHINE "CYCLE INCOMPLETE" ERROR WAS SHOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 1-2 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13169721 ↗
• MalfunctionDec 22, 2021Energy Output Problem; Energy Output Problem

  IT WAS REPORTED FOR A LIGASURE, "DEVICE WORKING FINE IN THE FIRST 10 MINUTES OF CASES THEN RANDOMLY STARTED MAKING ¿INCOMPLETE SEAL¿ NOISE WITH A MESSAGE ON FT10 GENERATOR SAYING SO. WE TRIED UNPLUGGING AND REPLUGGING DEVICE IN. THERE WERE NO STAPLES OR CLIPS PRESENT AND JAWS WERE WIPED CLEAN BUT INCOMPLETE SEAL ISSUE STILL PERSISTED. WE HAD TO OPEN ANOTHER REPROCESSED LIGASURE TO COMPLETE CASE." THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS TWO MINUTES ONLY TO REPLACE THE DEVICE. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062132 ↗
• MalfunctionNov 24, 2021Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE DEVICE STOPPED WORKING 15 MINUTES INTO THE PROCEDURE. SEALING RELATED ERROR MESSAGES APPEARED WHEN THE HANDLE WAS CLOSED TO HIT THE ACTIVATION BUTTON. THE COMPLAINT DEVICE WAS REPLACED WITH ANOTHER REPROCESSED DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872725 ↗
• MalfunctionNov 2, 2021Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THE PHYSICIAN NEEDED TO MANUALLY OPEN THE JAW BEFORE INITIAL USE. ADDITIONALLY, DURING THE PROCEDURE THERE WERE A FEW TIMES THE PHYSICIANS WERE BURNING FAT AND THE DEVICE KEPT GIVING "INCOMPLETE SEAL" MESSAGE WHEN TISSUE WAS ALREADY VERY MUCH COAGULATED AND VISIBLY CHARRED. PROVIDERS WERE ABLE TO COMPLETE THE PROCEDURE WITH THE SAME COMPLAINT DEVICE WITHOUT NEEDING TO OPEN ANOTHER. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739867 ↗
• InjuryAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE WHEN THE SURGEON WAS PULLING IT OUT OF THE TROCAR. THE DEVICE WAS NOT SAVED TO BE SENT BACK. THE BROKEN TIP DID NOT FALL INTO THE PATIENT THOUGH THERE WAS A SWITCH TO OPEN SURGERY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291873 ↗
• InjuryAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP BROKE WHEN THE SURGEON WAS PULLING IT OUT OF THE TROCAR. THE DEVICE WAS NOT SAVED TO BE SENT BACK. THE BROKEN TIP DID NOT FALL INTO THE PATIENT THOUGH THERE WAS A SWITCH TO OPEN SURGERY. THERE WAS NO PATIENT INJURY OR SURGICAL DELAY REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291872 ↗