Ligasure LS3112Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10884524002514), received between Mar 4, 2016 and Nov 30, 2022 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Device Alarm System; Failure to Cut; Failure to Fire; Detachment of Device or Device Component; Device Alarm System; Failure to Cut; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VAGINAL HYSTERECTOMY, THE DEVICE DID NOT WORK AT ALL. DID NOT BURN OR CUT. FORCE TRIAD GEN SAID ERROR, REGRADE AND RECONNECT. NO ENERGY DELIVERY. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT ONE PLASTIC SNAP WAS BROKEN AND MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885251 ↗
• InjurySep 1, 2020Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE. A SIMILAR DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10478893 ↗
• MalfunctionJun 27, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING HYSTERECTOMY, THE DEVICE DID NOT ACTIVATE. THEY OPENED ANOTHER ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE MEDTRONIC INITIAL VISUAL INSPECTION FOUND TWO BROKEN/MISSING SNAPS ON THE ELECTRODE JAW OF THE DEVICE. INVESTIGATION COMMUNICATIONS STATED THAT THERE WAS NOTHING FULLY DETACHED FROM THE DEVICE HENCE, NOTHING FELL INTO PATIENTS CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742248 ↗
• MalfunctionMay 17, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT ACTIVATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8621833 ↗
• MalfunctionApr 15, 2019Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT GAVE AN INVALID INSTRUMENT WARNING ONCE THE INSTRUMENT WAS PLUGGED IN AND WHEN THE DEVICE WAS BEING TRIED TO BE ACTIVATED ON TISSUE. A NEW HANDPIECE WAS OPENED, AND A NEW GENERATOR WAS USED. NO PATIENT INJURY. INITIAL INVESTIGATION FOUND THAT ONE BROKEN/MISSING SNAP ON THE ELECTRODE JAW. THE CUSTOMER WAS UNAWARE OF ANY SNAP PIN THAT BROKE OFF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514919 ↗
• MalfunctionApr 1, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE SUB TOTAL GASTRECTOMY, THE DEVICE WAS CONNECTED TO GENERATOR AND WAS ACTIVATED. ACTIVATION TONE AND END TONE SOUNDED, BUT IT DID NOT SEAL. THERE WAS NO RE-GRASP ALERT. RE-SNAPPED THE DISPOSABLE HAND INSTRUMENT ONTO THE REUSABLE FORCEPS AND TRIED AN ACTIVATION BUT FAILED TO SEAL. AFTER OPENING THE DEVICE, IT WAS NOT CHECKED IF THERE WAS BREAKAGE WITH THE ELECTRODE PINS IMMEDIATELY, SO IT WAS UNKNOWN WHEN THE PINS GOT BROKEN. IN ADDITION, AFTER ASSEMBLY, HANDED THE DEVICE TO THE SURGEON WITHOUT RATCHETING THE JAWS CLOSED ON THICK GAUZE. AFTER OCCURRENCE OF THE ISSUE, MANUAL SUTURING WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES AND THERE WAS NO BLEEDING. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8469648 ↗
• MalfunctionMar 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TOTAL VAGINAL HYSTERECTOMY, THE JAWS OF THE DEVICE BURNED THE PATIENT CAUSING BLISTER, WHEN THE DOCTOR PUT THE INSTRUMENT ON THE PATIENT'S STOMACH. NEW DEVICE WAS USED TO COMPLETE THE CASE. OINTMENT AND PLASTER WERE APPLIED TO THE BURN OF THE PATIENT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8405547 ↗
• InjuryFeb 3, 2019Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE. ANOTHER DEVICE WAS OPENED AND THE PROCEDURE WAS CONTINUED WITHOUT FAULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8300566 ↗
• MalfunctionDec 11, 2018Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE JAW WAS BROKEN AND THE PIECE WAS REMOVED FROM THE PATIENT'S CAVITY. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8150493 ↗
• InjuryNov 13, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WOULD NOT ACTIVATE. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER IDENTICAL DEVICE, WHICH FUNCTIONED PERFECTLY NORMAL. THERE WAS NO PATIENT INJURY. INITIAL INVESTIGATION FOUND THAT THE TWO BROKEN/MISSING SNAPS ON THE ELECTRODE JAW OF THE USED DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065348 ↗
• MalfunctionNov 8, 2018Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE ITEM WAS NOT WORKING AS EFFECTIVELY AS IT SHOULD AND WAS NOT PROVIDING A PROPER SEAL DURING THE SEALING OF VESSELS. THERE WAS BLEEDING, BUT NOT LIFE THREATENING. THERE WAS AN EVIDENCE OF ENERGY DELIVERED AND END TONE, BUT THERE WERE NO SUCCESSFUL SEALS MADE BEFORE THE ISSUE OCCURRED. ANOTHER ITEM OF THE SAME LOT WAS USED AND WORKED. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8051430 ↗
• MalfunctionNov 5, 2018Unstable; Unstable

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE PINS CONNECTING TO THE REUSABLE HANDLE KEPT COMING LOOSE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION AVAILABLE. INITIAL INVESTIGATION FOUND THAT ONE BROKEN/MISSING SNAP AND THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039007 ↗
• InjuryApr 27, 2018Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE MADE NO SEAL. THERE WAS NO MAJOR PROBLEM REGARDING BLEEDING AND NO TRANSFUSION NECESSARY. THERE WAS NO PATIENT INJURY. INVESTIGATION FOUND THAT ONE BROKEN/MISSING SNAP AND ONE DAMAGED SNAP ON THE ELECTRODE JAW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7469321 ↗
• InjuryApr 3, 2018Failure to Fire; Failure to Fire

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE AT THE TIME OF INITIAL SEALING, THE DEVICE WAS NOT ACTIVATED BY PRESSING THE ACTIVATION BUTTON. A NEW DEVICE WAS USED TO CONTINUE. THERE WAS NO PATIENT HARM. MANUFACTURER'S INITIAL EVALUATION FOUND ONE OF THE SNAPS TO HAVE BROKEN OFF. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7391939 ↗
• MalfunctionMar 15, 2018Detachment Of Device Component; Peeled/Delaminated; Detachment Of Device Component; Peeled/Delaminated

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE HAD AN INSULATION ISSUE WHEREIN THE GREY RUBBER PEELED OFF. THEY OPENED NEW DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7341796 ↗
• InjuryFeb 22, 2018Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, THERE WAS A SEALING ISSUE WITH THE DEVICE. THE DEVICE WOULD ACTIVATE AND CONTINUE TO SEAL BUT WOULD NOT REACH AN END TONE. AN ALARM WOULD OCCUR. THERE WAS NO PATIENT INJURY. EXAMINATION OF THE RECEIVED SAMPLE FOUND ONE OF THE SNAP PINS FROM THE JAWS OF THE DEVICE HAD BROKEN OFF AND WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7291029 ↗
• MalfunctionDec 7, 2017Device Stops Intermittently; Device Stops Intermittently

  THE CUSTOMER REPORTED THAT THE DEVICE WORKED AND COULD BE ACTIVATED FOR ONE MOMENT, THEN NO MORE REACTION. THERE WAS NO PATIENT INJURY. EXAMINATION OF THE RETURNED DEVICE FOUND IT HAD A BROKEN SNAP PIN THAT WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7098389 ↗
• MalfunctionDec 7, 2017Device Stops Intermittently; Defective Device; Device Stops Intermittently; Defective Device

  THE CUSTOMER REPORTED THAT THE DEVICE WORKED AND COULD BE ACTIVATED FOR ONE MOMENT, THEN NO MORE REACTION. THERE WAS NO PATIENT INJURY. EXAMINATION OF THE RETURNED DEVICE FOUND IT HAD A BROKEN SNAP PIN THAT WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7098383 ↗
• MalfunctionDec 5, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A COLON PROCEDURE, THE DEVICE WAS NOT ACTIVATED BY PRESSING THE ACTIVATION BUTTON FOR A FEW TIMES. THERE WAS NO PATIENT HARM AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. NOTHING FELL WITHIN THE PATIENT CAVITY. EXAMINATION OF THE RECEIVED SAMPLE BY MEDTRONIC FOUND A PIECE OF THE DEVICE HAD BROKEN OFF AND WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085255 ↗
• InjuryNov 27, 2017Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT ACTIVATE DURING A PROCEDURE. THE REPORTER INDICATED THAT THERE WAS NO PATIENT INJURY. THE INCIDENT DEVICE WAS RETURNED FOR EXAMINATION AND INSPECTION OF THE RECEIVED DEVICE IDENTIFIED THAT ONE OF THE SNAPS HAD BROKEN OFF AND WAS NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO DETERMINE IF THE BROKEN SNAP OCCURRED DURING OR AFTER THE PROCEDURE BUT NO DETAILS HAVE BEEN PROVIDED BY THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7061222 ↗
• MalfunctionAug 24, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT SEAL. AN END TONE INDICATING A COMPLETED SEALING CYCLE WAS HEARD WHEN THE ISSUE OCCURRED. THERE WAS NO PATIENT INJURY, AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816021 ↗
• InjuryAug 6, 2017Failure to Fire; Failure to Fire

  EXAMINATION OF A RETURNED COMPLAINT DEVICE FOUND THAT THREE SNAPS WERE BROKEN AND MISSING. THE CUSTOMER CANNOT CONFIRM IF THE PINS FELL WITHIN THE PATIENT. IT IS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6769856 ↗
• MalfunctionJul 17, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, ONE OF THE ELECTRODE PINS BROKE WHEN THE DEVICE WAS ASSEMBLED. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE. NO PATIENT INJURY OCCURRED OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6720182 ↗
• MalfunctionJan 22, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS NOT RECOGNIZED WHEN CONNECTED TO A FORCETRIAD GENERATOR. A NEW DEVICE WAS CONNECTED TO THE SAME GENERATOR AND WORKED WELL. EXAMINATION OF THE RECEIVED DEVICE ON JANUARY 6TH FOUND ONE OF THE SNAP PINS FROM THE JAW IS BROKEN AND MISSING. THE CUSTOMER CONFIRMED THE PIECE DID NOT FALL WITHIN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6269177 ↗
• MalfunctionNov 3, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE WOULD NOT ACTIVATE WHEN THE HAND SWITCH WAS USED. THE DEVICE WAS IN USE WITH A FORCETRIAD GENERATOR, AND THE SAME ISSUE OCCURRED WITH OTHER DEVICES THAT WERE TESTED. NO PATIENT INJURY OCCURRED. EXAMINATION OF THE RECEIVED SAMPLE ON OCTOBER 31, 2016 FOUND THAT A SNAP PIN IS MISSING. THE CUSTOMER REPORTED THAT NO PART OF THE DEVICE FELL WITHIN THE PATIENT CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6077863 ↗