NA COVLF1737Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888551044462), received between Oct 8, 2018 and Jul 23, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2019Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC HYSTERECTOMY PROCEDURE WITH A REPROCESSED MARYLAND LIGASURE JAW SEALER/DIVIDER AND DURING THE PROCEDURE, THE JAW LOCKED OPEN. THE PHYSICIAN WAS UNABLE TO CLOSE IT AND WAS FORCED TO REMOVE THE DEVICE BY PULLING IT AND THE PORT OUT, CAUSING SOME TISSUE DAMAGE. THE CASE WAS COMPLETED USING A NEW LIGASURE (NOT REPROCESSED) AND THERE WAS NO LONG-TERM HARM TO THE PATIENT. THIS HAS BEEN ASSESSED AS A REPORTABLE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8819731 ↗
• MalfunctionJan 30, 2019Mechanical Problem

  THE LIGASURE HAND PIECE DID NOT WORK. WE TRIED TWO DIFFERENT MACHINES. WHEN THAT DID NOT CORRECT THE PROBLEM, WE SWITCHED HAND PIECES AND THAT CORRECTED THE PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8288777 ↗
• MalfunctionJan 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY PROCEDURE WITH A 5MM MARYLAND JAW SEALER/DIVIDER, 37CM AND THE SURGEON ADVISED THE LIGASURE WORKED THE FIRST TIME PROPERLY, THEN FELT THAT IT WAS STICKING AND NOT CAUTERIZING. THE DEVICE DID CONTACT THE PATIENT AND THE TIPS WERE STICKING TO HEALTHY TISSUE. THERE WAS NO END TONE OR ERROR TONE FROM THE DEVICE. ANOTHER REFURBISHED MARYLAND LIGASURE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT CONSEQUENCE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8259381 ↗
• InjuryOct 8, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRECTOMY PROCEDURE WITH A STERILMED LIGASURE 5MM MARYLAND JAW SEALER/DIVIDER AND SUFFERED BLEEDING. THE PHYSICIAN HAD TO REOPEN A BARIATRIC PATIENT AFTER A SLEEVE GASTRECTOMY BECAUSE OF POST-OPERATIVE BLEEDING. THE SURGEON SAID BLEEDING WAS COMING FROM TWO VESSELS SEALED WITH A STERILMED LIGASURE MARYLAND. THE SAME DAY URGENT REOPERATION WAS DONE TO STOP THE BLEEDING. PATIENT WAS DOING WELL AFTER REOPERATION.

  Patient problems: Blood Loss; Shock

  MAUDE report 7943079 ↗