Ligasure LS3092Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884524002156), received between Mar 29, 2016 and Jul 20, 2020 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Device Alarm System; Detachment of Device or Device Component; Device Alarm System; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS GRASPED IN A GAUZE BUT ALARM SOUNDED AFTER FOUR SECONDS. THE DEVICE WAS RECONNECTED BUT IT DID NOT RESOLVE THE ISSUE. REPLACED WITH NEW SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT ONE PLASTIC TAB WAS BROKEN AND MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 10298748 ↗
• MalfunctionSep 4, 2019Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO MASTECTOMY, WHEN THE DEVICE WAS INSERTED INTO THE GENERATOR, THE PIN BROKE. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8959237 ↗
• MalfunctionJun 27, 2019Energy Output Problem; Energy Output Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH), THE DEVICE DID NOT CAUTERIZE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8742721 ↗
• InjuryApr 9, 2019Failure to Fire; Failure to Fire

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496485 ↗
• MalfunctionMar 7, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE WAS PLUGGED INTO GENERATOR AND WOULD NOT ACTIVATE. NO SOUND OR SEAL WOULD OCCUR SO ANOTHER DEVICE WAS OPENED, WHICH WORKED AND COMPLETED THE PROCEDURE. NOTHING BROKE OFF DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE INITIAL EVALUATION OF THE INCIDENT DEVICE 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 8399401 ↗
• MalfunctionDec 14, 2018Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE 2 JAWS OF THE DEVICE BROKE. THE PIECES OF THE JAWS WERE RECOVERED AND PUT IN A BOTTLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8165329 ↗
• MalfunctionMar 22, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER PRE-OPERATIVELY THE DEVICE DID NOT ACTIVATE. ELECTRODE HAD ACTIVATED BUT WITH NO EFFECT. ANOTHER LIGASURE WORKED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7362943 ↗
• MalfunctionJan 29, 2018Energy Output To Patient Tissue Incorrect; Failure to Cut; Energy Output To Patient Tissue Incorrect; Failure to Cut

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD NO SEALING AND NO CUTTING DURING USE.

  Patient problems: No Patient Involvement

  MAUDE report 7226139 ↗
• MalfunctionNov 1, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE PLASTIC PIN ON THE DEVICE BROKE PRIOR TO USE ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6995121 ↗
• MalfunctionSep 6, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT ACTIVATE. NO PATIENT INJURY OCCURRED OR MEDICAL INTERVENTION REQUIRED. EXAMINATION OF THE RECEIVED DEVICE BY MEDTRONIC FOUND A SNAP PIN WAS BROKEN AND MISSING. THE CUSTOMER WAS NOTIFIED AND CONFIRMED THAT THE PIECE DID NOT DETACH DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6846991 ↗
• MalfunctionJun 1, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT DURING ASSEMBLY OF THE DEVICE, ONE OF THE PRONGS BROKE OFF. THE DEVICE HAD NOT BEEN USED ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6606700 ↗
• MalfunctionMay 11, 2017Energy Output To Patient Tissue Incorrect; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT PERFORM A COMPLETE SEAL. THERE WAS NO PATIENT INJURY AND ANOTHER DEVICE OF THE SAME TYPE WAS USED TO CONTINUE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6562275 ↗
• MalfunctionDec 22, 2016Detachment Of Device Component; Energy Output To Patient Tissue Incorrect; Detachment Of Device Component; Energy Output To Patient Tissue Incorrect

  THE CUSTOMER REPORTED THAT DURING A J-POUCH BOWEL RESECTION, NO THERMAL SPREAD WAS OBSERVED WHEN THE DEVICE WAS ACTIVATED. NO PATIENT INJURY RESULTED AND A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. A SEALING TONE WAS HEARD, BUT IT IS UNKNOWN IF AN END TONE OR REGRASP ALARM OCCURRED. EXAMINATION OF THE RECEIVED DEVICE ON DECEMBER 9, 2016 FOUND ONE OF THE SNAPS ON THE JAW WAS BROKEN AND MISSING. THE CUSTOMER REPORTED THAT NO PIECES FELL INTO THE PATIENT CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6200299 ↗
• MalfunctionOct 12, 2016Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE WAS BROKEN WITHIN THE PACKAGING. THE ISSUE WAS IDENTIFIED DURING DISTRIBUTION AND BEFORE USE IN A PROCEDURE. EXAMINATION OF THE DEVICE ON (B)(6) 2016 FOUND THE ACTIVATION BUTTON HAD DETACHED.

  Patient problems: No Patient Involvement

  MAUDE report 6024821 ↗
• InjuryJun 27, 2016Detachment Of Device Component; Failure to Deliver Energy; Detachment Of Device Component; Failure to Deliver Energy

  THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE STOPPED WORKING DURING AN ABDOMINAL HYSTERECTOMY. ANOTHER DEVICE OF THE SAME TYPE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION WITH A BROKEN AND MISSING SNAP PIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5751068 ↗
• InjuryMar 29, 2016Break; Failure to Power Up; Component Missing

  THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE HAD NO POWER. A NEW DEVICE WAS USED WITHOUT FURTHER CONSEQUENCES. NO PATIENT INJURY REPORTED. NO MEDICAL INTERVENTION REQUIRED. WHEN THE DEVICE WAS RECEIVED FOR INVESTIGATION ON (B)(6) 2016, IT WAS NOTED THAT THERE WAS ONE BROKEN AND MISSING SNAP PIN. SITE WAS UNABLE TO VERIFY LOCATION OF MISSING SNAP PIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5532258 ↗