LigaSure LF1212A (UDI 10884521186033)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521186033), received between Apr 25, 2018 and Dec 8, 2022 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Energy Output Problem; Energy Output Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE RISK FACTORS OF DELAYED POST-HEMORRHOIDECTOMY BLEEDING FOLLOWING DEVICE HEMORRHOIDECTOMY BETWEEN MARCH 2009 TO DECEMBER 2017. DEVICE WAS APPLIED ON THE PEDICLES OF HEMORRHOIDS TO LIGATE THE VESSELS. THERE WERE 437 PATIENTS IN THE STUDY AND 22 PATIENTS DEVELOPED DELAYED BLEEDING. 18 OUT OF 22 PATIENTS REQUIRED HOSPITALIZATION AND 12 PATIENTS REQUIRED SURGICAL HEMOSTATIC INTERVENTION. TWO PATIENTS DEVELOPED RECURRENT BLEEDING AND WERE RE-ADMITTED. BOTH PATIENTS UNDERWENT SURGICAL HEMOSTASIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15943420 ↗
• MalfunctionJun 28, 2022Therapeutic or Diagnostic Output Failure

  COVIDIEN LIGASURE CURVED SMALL JAW OPEN SEALER/DIVIDER REF #LF1212A LOT #S1JH726X. LIGASURE NOT WORKING. ATTEMPTED TWO DIFFERENT MACHINES. NEW LIGASURE DISPENSED TO FIELD AND WORKS PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842631 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE STUDY, BETWEEN OCTOBER 2017 AND OCTOBER 2018, 20 PATIENTS WITH 40 GROINS REQUIRING BILATERAL INGUINOFEMORAL LYMPHADENECTOMY (IFL) WERE INCLUDED IN THIS STUDY. TEN PATIENTS WERE ALLOCATED TO IFL WITH LIGASURE IN THE RIGHT GROIN AND TEN PATIENTS WERE ALLOCATED TO LIGASURE IN THE LEFT GROIN. POSTOPERATIVE SHORT-TERM COMPLICATIONS REQUIRING TREATMENT OCCURRED IN 6/20 GROINS TREATED WITH LIGASURE: 1 WOUND INFECTION; 4 WOUND INFECTION AND LYMPHOCELE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10789314 ↗
• MalfunctionApr 1, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE LIGASURE HANDLE WAS STICKING CLOSED DURING USE. PATIENT INVOLVEMENT INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 9911280 ↗
• MalfunctionMar 24, 2020Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING MASTECTOMY, THE HAND PIECE'S JAW LOCKED AND WOULD NOT OPENED WHILE REMOVING BREAST TISSUE. ANOTHER HAND PIECE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9875990 ↗
• MalfunctionJul 25, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING TOTAL THYROIDECTOMY WITH CERVICAL EMPTYING, THE DEVICE DID NOT SEAL AND LITTLE AMOUNT OF BLEEDING OCCURRED. SUTURING AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828424 ↗
• MalfunctionJun 4, 2019Device Alarm System; Component Incompatible

  WHEN CIRCULATING RN PLUGGED COVIDIEN LIGASURE DEVICE INTO GENERATOR. THE GENERATOR KEPT GIVING THE ERROR MESSAGE "INSTRUMENT NOT RECOGNIZED." FAULTY ITEM IMMEDIATELY REMOVED FROM OPERATING ROOM.

  Patient problems: No Information

  MAUDE report 8666282 ↗
• InjuryMar 28, 2019Energy Output Problem; Separation Problem; Energy Output Problem; Separation Problem

  ACCORDING TO THE REPORTER, DURING CESAREAN SECTION WITH TUBAL LIGATION, THE SURGEON REPORTED THAT THE TISSUE WERE STICKING TO THE JAWS, BUT THE JAWS WAS NOT STUCK, IT COULD BE OPENED AND CLOSED. HOWEVER THE SEAL WAS COMPROMISED WHEN THEY PULLED THE JAWS FROM THE SEAL. 24 HOURS POST-OP, PATIENT DEVELOPED BLEEDING IN THE ABDOMEN AND WAS ADMITTED INTO THE OPERATING ROOM AND TRANSFUSED WITH BLOOD. PATIENT HAD RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8461918 ↗
• MalfunctionMar 14, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE CLAMP PERFORMED THE SEAL INTERMITTENTLY WITH END TONE, CLEANED VERY WELL AND SEVERAL TIMES THE CLAMP. RESTARTED THE GENERATOR, CHANGED THE CLAMP FROM ONE PORT TO ANOTHER, BUT ISSUE WAS NOT SOLVED. FINALLY, THE CLAMP WAS CHANGED WITH A NEW ONE THUS SOLVING THE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8422028 ↗
• MalfunctionApr 25, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY KNIFE LEVER AND STUCK IN DOWN POSITION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7461611 ↗