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LigaSure LF1844Recalls & reported problems

Covidien LP · Blunt Tip Laparoscopic Sealer/Divider Nano-coated · Class 2

Quick summary

This Covidien LigaSure LF1844 is a laparoscopic sealer and divider that cuts tissue while sealing blood vessels to stop bleeding. Its reports mostly describe the device not delivering energy or failing to seal, sometimes with no alarm, plus jaws that are hard to open and close. There are 50 reports, no deaths, and 4 injuries. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
50
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10884521705890), received between Jul 18, 2018 and Feb 2, 2026 — classified as 4 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (35 reports).

1 other recall cover devices cleared under the same FDA submission (K162941); 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Energy Output Problem35
  • Difficult to Open or Close10
  • Device Alarm System5
  • Detachment of Device or Device Component2
  • Mechanical Jam2
  • Break1
  • Device Contaminated During Manufacture or Shipping1
  • Difficult or Delayed Activation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions26
  • No Consequences Or Impact To Patient14
  • Hemorrhage/Blood Loss/Bleeding5
  • Blood Loss4
  • Insufficient Information4
  • No Code Available3
  • Device Embedded In Tissue or Plaque1

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 2, 2026Energy Output Problem

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE BLUNT TIP SEALER DIVIDER LF1844 WAS APPLIED TO THE OMENTUM IN THE FIRST STEP OF THE PROCEDURE TO CREATE A WINDOW. THE DEVICE WAS PLUGGED INTO AN FT10 GENERATOR. THERE WAS AN ENERGY ACTIVATION AND SEALING ISSUE WITH NO SEAL ACHIEVED, NO EVIDENCE OF ENERGY DELIVERY, AND END TONES HEARD. THERE WAS NO RE-GRASP ALERT. NO GOOD SEALS OCCURRED PRIOR TO THE ISSUE AND THE TISSUE BEING SEALED WAS 1-2MM THICK OMENTUM. BLEEDING OCCURRED DURING THE PROCEDURE AND THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES. BLOOD TRANSFUSION WAS NOT NECESSARY. THE PATIENT WAS NOT ON ANY MEDICATIONS (ANY MEDS THAT CAN AFFECT BLOOD CLOTTING OR MAY CONTRIBUTE TO BLEEDING). CLIPPING WAS DONE TO STOP THE BLEEDING AND ANOTHER LIGASURE DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 24231173 ↗
  • MalfunctionSep 17, 2024Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, THE DEVICE HAD SEALING INADEQUATE/PARTIAL (WITH EVIDENCE OF ENERGY DELIVERY AND END TONES HEARD) AND NO ALARM WHEN SEALING BETWEEN THE THIN TO MEDIUM OMENTUM ALONGSIDE THE STOMACH. ANOTHER DEVICE WAS USED SUCCESSFULLY WITH THE SAME GENERATOR. THE PATIENT HAD BLED AFTER CUTTING ON THE SEAL SITE AND SURGICAL TIME WAS EXTENDED. THERE WAS NO BLOOD TRANSFUSION DONE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 20238403 ↗
  • MalfunctionApr 26, 2024Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD NO SEAL. ANOTHER DEVICE WAS USED USING THE SAME GENERATOR AND IT WORKED FINE. DEVICE WAS CONNECTED TO A GENERATOR WHEN THE EVENT HAPPENED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19193179 ↗
  • MalfunctionDec 1, 2023Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING ROBOT-ASSISTED SURGERY, THE DEVICE WAS CONNECTED TO THE GENERATOR AND EVEN THOUGH OUTPUT TEST WAS PERFORMED, ACTIVATION SOUND AND ERROR SOUND WAS NOT MADE AND DID NOT SEAL. THE CONNECTION WAS PERFORMED REPEATEDLY AND EVEN THOUGH THE SAME OPERATION WAS PERFORMED, IT DID NOT OPERATE AND USAGE WAS STOPPED AND REPLACED WITH A NEW ONE. OTHER DEVICE WORKED FINE WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18246787 ↗
  • MalfunctionJun 2, 2023Difficult to Open or Close; Difficult to Open or Close

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, DEVICE JAW WAS DIFFICULT TO OPEN AND CLOSE.

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

    MAUDE report 17054344 ↗
  • MalfunctionJun 23, 2022Difficult to Open or Close; Difficult to Open or Close

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP OF INSTRUMENT DID NOT OPEN COMPLETELY, OUT OF THE BOX FAILURE. JAWS WERE PARTIALLY OPEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT OF THE SAME CODE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14792910 ↗
  • MalfunctionApr 27, 2022Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING DISSECTION OF THE GREATER CURVATURE FAT FROM THE STOMACH, THE LIGASURE WAS ABLE TO CUT BUT WAS NOT SEALING. THERE WAS NO REGRASP ALERT NOR ENERGY DELIVERY NOTED BUT AN END TONE WAS HEARD. ANOTHER LIGASURE WAS OPENED TO SOLVE THE PROBLEM AND SEAL THE BLEEDING AREAS. THE SAME GENERATOR (LS10) WAS USED FOR BOTH LIGASURES. THERE WAS A BLEEDING OF LESS THAN 250CC.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 14227375 ↗
  • MalfunctionMar 25, 2022Device Alarm System; Energy Output Problem; Failure to Cut; Device Alarm System; Energy Output Problem; Failure to Cut

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE'S CUTTING WAS NOT SUFFICIENT. THE DEVICE ALSO HAD PARTIAL SEAL AND THERE WAS BLEEDING AFTER PROCEDURE. THERE WAS A REGRASP ALARM REPORTED. THERE WAS AN END TONE HEARD AND THERE WAS AN EVIDENCE OF ENERGY DELIVERY. IMMEDIATE HEMOSTASIS WAS POSSIBLE DUE TO INTRAOPERATIVE BLEEDING. THE BLEEDING WAS VERY SMALL AMOUNT. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13908990 ↗
  • MalfunctionMar 23, 2022Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, THE DEVICE SEALED OVER VESSEL AND REACHED COMPLETE CYCLE TONE. VESSEL WAS CUT AFTER SEALING. SEAL WAS INCOMPLETE AND BEGAN SQUIRTING/EXCESSIVELY BLEEDING. BLEEDING CAUSED AN ADDITIONAL 10 MIN PROCEDURE TIME IN ORDER TO STOP THE BLEED. AFTER MULTIPLE ATTEMPTS TO SEAL ANOTHER DEVICE WAS OPENED BUT ACCOUNT ACCIDENTALLY DISCARDED BOTH DEVICES. THERE WAS NO PATIENT INJURY.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

    MAUDE report 13866501 ↗
  • MalfunctionDec 10, 2021Retraction Problem; Mechanical Jam; Retraction Problem; Mechanical Jam

    ACCORDING TO THE REPORTER, DURING ROBOT ASSISTED LAPAROSCOPIC SURGERY (UROLOGICAL SURGERY), THE DEVICE WAS DIFFICULT TO OPEN/NOT POSSIBLE. THE JAW WAS NOT PARTIALLY OPENED AND THE KNIFE BECAME UNABLE TO RETURN. THE TISSUE CAME OFF THE JAWS, SO IT WAS RELEASED AS IT WAS. A NEW PRODUCT WAS TAKEN OUT AND USED WITHOUT ANY ISSUES ENCOUNTERED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12977266 ↗
  • MalfunctionNov 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HIATAL HERNIA REPAIR, THE DEVICE HAD NO ISSUES. THERE WAS NO VISIBLE DEFECTS TO HANDPIECE, AND THE DEVICE WAS WORKING AS INTENDED HOWEVER, THERE WAS A SMALL METAL COIL FOUND NEAR THE PATIENT'S HIATUS THAT APPEARED RANDOMLY. THE METAL COIL LIKE PIECE WAS REMOVED. SURGEON KEPT USING SAME LIGASURE DEVICE TOO. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12894693 ↗
  • MalfunctionOct 14, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE SEALED INADEQUATELY, THERE WAS RE-GRASP ALARM, AND END TONE WAS OBSERVED. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12632849 ↗
  • MalfunctionSep 10, 2021Break; Detachment of Device or Device Component; Difficult to Open or Close; Break; Detachment of Device or Device Component; Difficult to Open or Close

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT HEMICOLECTOMY LITHOTOMY WITH CONTOUR STAPLER, THE HANDLE WAS BROKEN AND THE JAW COULD NOT MOVE; THE EXTREMITY REMAINED OPEN WHILE IN THE ABDOMINAL CAVITY. THE DOCTOR WAS UNABLE TO CLOSE THE JAW TO GET IT OUT OF THE CAVITY AND TOOK ANOTHER INSTRUMENT TO CLOSE THE JAW IN ORDER TO GET IT OUT. THE SURGERY WAS FINALLY COMPLETED USING ANOTHER INSTRUMENT TO REMOVE THE BROKEN ONE AND USED ANOTHER NEW ONE TO COMPLETE THE PROCEDURE. THE WHITE COATING CERAMIC FELL INTO THE PATIENT'S CAVITY BUT THE PIECE WAS REMOVED. PATIENT WAS UNDER ANESTHESIA. THERE WAS A DELAY IN SURGERY FOR MORE THAN 30 MIN. THERE WAS NO PATIENT INJURY.

    Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

    MAUDE report 12456801 ↗
  • MalfunctionAug 10, 2021Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A BARIATRIC PROCEDURE (MINI GASTRIC BYPASS), THE TWO DEVICES WERE NOT SEALING VESSEL. DEVICES WERE USED ALONG WITH LS10 UNIT. IT CONTINUED WITH THE SEALING BUT DID NOT SEAL AS WELL. BEFORE GETTING INTO TROCAR, THEY ALWAYS CHECKED THAT ENERGY WAS DELIVERED AND MACHINE WAS READY TO USE. DURING THIS THEY USED GAUGE PIECE AND THE SAME HAPPENED. THEY THEN TRIED ONCE INTO THE TROCAR ON PATIENT, BUT SAME THING CONTINUED. IT HAPPENED IN OR (OPERATING ROOM) ITSELF, BUT THERE WAS NO TROUBLE TO PATIENT DUE TO THE DEVICE ISSUE AS IT DID NOT SEAL. THERE WAS NO END TONE. SEAL CYCLE CONTINUED AND DOCTOR LEFT THE SEAL AND THEN ERROR SOUND WAS HEARD. THERE WAS NOT MUCH BLEEDING AS DOCTOR IS A USER OF LIGASURE SINCE LAST MANY YEARS AND BLADE WAS NOT RAN WITHOUT ENDING THE CYCLE. DOCTOR TRIED 3-6 TIMES ON DIFFERENT TISSUES, BUT IT DID NOT SEAL. TISSUE BUNDLES WERE GRASPED PROPERLY AND WAS NOT THAT THICK AS HE WAS SEPARATING ON OMENTUM PART. PROCEDURE WAS COMPLETED WITH ANOTHER LIGASURE PROBE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12300673 ↗
  • MalfunctionAug 10, 2021Device Alarm System; Energy Output Problem; Device Alarm System; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A BARIATRIC PROCEDURE (MINI GASTRIC BYPASS), THE TWO DEVICES WERE NOT SEALING VESSEL. DEVICES WERE USED ALONG WITH LS10 UNIT. IT CONTINUED WITH THE SEALING BUT DID NOT SEAL AS WELL. BEFORE GETTING INTO TROCAR, THEY ALWAYS CHECKED THAT ENERGY WAS DELIVERED AND MACHINE WAS READY TO USE. DURING THIS THEY USED GAUGE PIECE AND THE SAME HAPPENED. THEY THEN TRIED ONCE INTO THE TROCAR ON PATIENT, BUT SAME THING CONTINUED. IT HAPPENED IN OR (OPERATING ROOM) ITSELF, BUT THERE WAS NO TROUBLE TO PATIENT DUE TO THE DEVICE ISSUE AS IT DID NOT SEAL. THERE WAS NO END TONE. SEAL CYCLE CONTINUED AND DOCTOR LEFT THE SEAL AND THEN ERROR SOUND WAS HEARD. THERE WAS NOT MUCH BLEEDING AS DOCTOR IS A USER OF LIGASURE SINCE LAST MANY YEARS AND BLADE WAS NOT RAN WITHOUT ENDING THE CYCLE. DOCTOR TRIED 3-6 TIMES ON DIFFERENT TISSUES, BUT IT DID NOT SEAL. TISSUE BUNDLES WERE GRASPED PROPERLY AND WAS NOT THAT THICK AS HE WAS SEPARATING ON OMENTUM PART. PROCEDURE WAS COMPLETED WITH ANOTHER LIGASURE PROBE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12300652 ↗
  • MalfunctionAug 8, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A BARIATRIC PROCEDURE (MINI GASTRIC BYPASS), THE DEVICE WAS NOT SEALING VESSEL. IT CONTINUED WITH THE SEALING BUT DID NOT SEAL AS WELL. BEFORE GETTING INTO TROCAR, THEY ALWAYS CHECKED THAT ENERGY WAS DELIVERED AND MACHINE WAS READY TO USE. DURING THIS THEY USED GAUGE PIECE AND THE SAME HAPPENED. THEY THEN TRIED ONCE IN TO THE TROCAR ON PATIENT BUT SAME THING CONTINUED. IT HAPPENED IN OR (OPERATING ROOM) ITSELF BUT THERE WAS NO TROUBLE TO PATIENT DUE TO THE DEVICE ISSUE AS IT DID NOT SEAL. THERE WAS NO END TONE. SEAL CYCLE CONTINUED AND DOCTOR LEFT THE SEAL AND THEN ERROR SOUND WAS HEARD. THERE WAS NOT MUCH BLEEDING AS DOCTOR IS A USER OF LIGASURE SINCE LAST MANY YEARS AND BLADE WAS NOT RUN WITHOUT ENDING THE CYCLE. DOCTOR TRIED 3-6 TIMES ON DIFFERENT TISSUES BUT IT DID NOT SEAL. TISSUE BUNDLES WERE GRASPED PROPERLY AND WASN'T THAT THICK AS HE WAS SEPARATING ON OMENTUM PART. PROCEDURE WAS COMPLETED WITH ANOTHER LIGASURE PROBE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12292112 ↗
  • MalfunctionJul 12, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE WAS NOT SEALING CORRECTLY. IT WAS NOTED THAT THERE WAS NO RE GRASP ALARM BUT WITH END TONE AND ENERGY DELIVERY. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12150858 ↗
  • MalfunctionApr 14, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, THE DEVICE WAS NOT SEALING THE VESSEL. IT CONTINUED WITH THE SEALING BUT DID NOT SEAL AS WELL.

    Patient problems: Insufficient Information

    MAUDE report 11664505 ↗
  • MalfunctionApr 6, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE HAD AN INADEQUATE SEAL. BLEED WAS NOTICED IMMEDIATELY AND WAS RESEALED. IT WORKED ON SEALS THAT FOLLOWED. THE SEAL THAT FAILED WAS ONE OF THE FIRST ACTIVATIONS OF THE CASE. THERE WAS NO REGRASP ALERT. THERE WAS AN END TONE REPORTED AND EVIDENCE OF ENERGY DELIVERY. THE BLEEDING WAS MINIMAL AND TRANSFUSION WAS NOT NECESSARY. ANOTHER DEVICE WAS USED AND WORKED FINE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11620799 ↗
  • MalfunctionMar 18, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WERE 2-3 INSTANCES OF THIS UNIT NOT SEALING AND REQUIRING ADDITIONAL SEAL CYCLES TO STOP THE BLEEDING, THERE WAS NO REGRASP ALARM AND END TONE WAS PRODUCED. ULTIMATELY, THE HANDPIECE WORKED AND THE CASE WAS FINISHED USING IT. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11517615 ↗
  • MalfunctionMar 11, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE HAD A SEALING ISSUE. THERE WAS NO REGRASP ALERT AND NO ENERGY DELIVERY BUT THERE WAS AN END TONE. THE DEVICE WAS NOT SEALING, THIS HAS BEEN HAPPENING FOR SEVERAL YEARS NOW AT THIS FACILITY. THE PREVIOUS REP THOUGHT IT MIGHT BE THE FT10'S. THEY HAVE BEEN SENT BACK SEVERAL TIMES FOR SERVICING. TRIED SEVERAL DIFFERENT DEVICE UNITS. THESE WERE NOT SEALING AT ALL EVEN AFTER DOUBLE AND TRIPLE SEALING. THE SURGEON DIVIDED THE SHORT GASTRIC VESSELS ON HIS SLEEVES AND THE DEVICE DID NOT SEAL AT ALL AND THEN THE VESSELS STARTED BLEEDING. THE SURGEON TRIED THE COMPETITOR DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: Insufficient Information

    MAUDE report 11462546 ↗
  • MalfunctionMar 11, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE HAD A SEALING ISSUE. THERE WAS NO REGRASP ALERT AND NO ENERGY DELIVERY BUT THERE WAS AN END TONE. THE DEVICE WAS NOT SEALING, THIS HAS BEEN HAPPENING FOR SEVERAL YEARS NOW AT THIS FACILITY. THE PREVIOUS REP THOUGHT IT MIGHT BE THE FT10'S. THEY HAVE BEEN SENT BACK SEVERAL TIMES FOR SERVICING. TRIED SEVERAL DIFFERENT DEVICE UNITS. THESE WERE NOT SEALING AT ALL EVEN AFTER DOUBLE AND TRIPLE SEALING. THE SURGEON DIVIDED THE SHORT GASTRIC VESSELS ON HIS SLEEVES AND THE DEVICE DID NOT SEAL AT ALL AND THEN THE VESSELS STARTED BLEEDING. THE SURGEON TRIED THE COMPETITOR DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: Insufficient Information

    MAUDE report 11462416 ↗
  • MalfunctionMar 9, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING LAP SLEEVE GASTRECTOMY, THE DEVICE HAD NO SEAL. THE DEVICE WAS ACTIVATED AND END TONE WAS ACHIEVED. AFTER THEY CUT AND RELEASED THE JAWS, THE VESSEL IMMEDIATELY BLED AS IF IT HAD BE CUT WITHOUT BEING SEALED. IT WAS LESS THAN 250 CC AND BOTH SIDES OF THE VESSEL WERE ULTIMATELY FOUND AND SEALED BY USING A DOUBLE SEAL TECHNIQUE TO ENSURE THE SEAL WAS CREATED. PREVIOUS DEVICE PERFORMED NORMALLY WITH THIS GENERATOR. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11444359 ↗
  • MalfunctionMar 4, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE VESSELS WERE NOT SEALING. THE DEVICE WAS ACTIVATED PROPERLY, END TONE WAS HEARD AND DID NOT CUT UNTIL END TONE OR SECOND SEAL. THE VESSELS BY THE SPLEEN WERE NOT SEALING, AND IT ALSO HAD ISSUES OF THE SHORT GASTRIC ON THE MESENTERY SIDE THAT BLED AFTER THEY HAD DISSECTED THE STOMACH OFF THE MESENTERY. THESE VESSELS APPEARED TO BE SEALED BUT WHEN THEY WENT BACK TO STAPLE, THEY WERE BLEEDING. THIS WAS HAPPENING A LOT WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11411532 ↗
  • InjuryMar 3, 2021Energy Output Problem; Energy Output Problem

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY AFTER PERFORMING A SEAL, THE TISSUE WAS CUT AND A VESSEL BLED WITH MINIMAL BLOOD LOSS. ONE SIDE OF THE CUT VESSEL WAS ABLE TO BE SEALED AFTERWARDS. HOWEVER, THE OTHER SIDE OF THE VESSEL REQUIRED CLIPS TO CLOSE THE BLEED. THIS LED TO 45 MINUTES OF ADDITIONAL OPERATIVE TIME ALONG WITH NEED TO PLACE TWO ADDITIONAL 5MM TROCAR PORTS FOR BETTER ACCESS. THERE WAS NO BLOOD TRANSFUSION OCCURRED. IT WAS NOTED THAT THERE WAS NO RE GRASP ALARM BUT WITH END TONE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 11407783 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162941. One submission often covers many models, so check the product and lot details in each record.

  • Z-0495-2022 · Dec 6, 2021 · Terminated
    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.