Signia SIGLU45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521543492), received between Jul 2, 2018 and Apr 20, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 reports).

14 other recalls cover devices cleared under the same FDA submission (K160176); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOADING IN A WHIPPLE PROCEDURE, THE SILVER SHAFT OF THE LOADING UNIT CAME COMPLETELY OFF EXPOSING THE BLACK INNER MECHANICS OF THE LOADING UNIT. A NEW LOADING UNIT WAS USED TO RESOLVE THE ISSUE. THE DEVICE WAS NOT USED ON PATIENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695007 ↗
• MalfunctionOct 23, 2020Failure to Read Input Signal; Failure to Fire; Failure to Read Input Signal; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ROUX-EN-Y, THE SURGEON WAS GOING TO DO JEJUNOJEJUNOSTOMY, AND THE DEVICE COULD NOT BE FIRED. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT RECOGNIZE WHAT EITHER CARTRIDGE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10730351 ↗
• MalfunctionJul 2, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PULMONARY ARTERY RESECTION IN AN OPEN THORACOTOMY PROCEDURE, THE DEVICE LOCKED ON PULMONARY ARTERY. THE JAWS OPENED EASILY BY USING THE JOYSTICK OF THE POWERED STAPLER. AFTER THAT THE SURGEON WAS NOT ABLE TO PUSH THE GREEN BUTTON BECAUSE THE GREEN LIGHT DID NOT APPEAR ON THE HANDLE. ALL THE SETUP PREPARATIONS WERE DONE CORRECTLY. BOTH THE HANDLE AND THE ADAPTER LOADED SUCCESSFULLY ALONG WITH THE CARTRIDGE AND THE LOADING UNIT. UPON CHECKING, THE HANDLE, SHELL, ADAPTER AND THE CARTRIDGE WERE OKAY ON THE SCREEN. THE BATTERY WAS FULLY CHARGED. THE TEST FOR CLOSING AND OPENING THE JAWS OF THE CARTRIDGE AND ALSO THE ARTICULATION TEST WERE DONE AND EVERYTHING SEEMED OKAY BUT THE GREEN BUTTON WAS NOT APPEARING ON THE POWER HANDLE. HENCE, THE SURGEONS WERE NOT ABLE TO PUSH THE GREEN BUTTON. THE SURGEON CHANGED THE SHELL AND OPENED A NEW STERILE SHELL TO FIRE THE DEVICE THEN ALL THE PROBLEMS WERE RESOLVED. THE LOADING UNIT AND CARTRIDGE THAT DID NOT FIRE WITH THE FIRST SHELL FIRED CORRECTLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223745 ↗
• MalfunctionApr 16, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOBECTOMY PROCEDURE, WHEN STAPLING THE PULMONARY VEIN, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THE STAPLER DID NOT FIRE. ANOTHER COMPETITIVE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968004 ↗
• MalfunctionFeb 4, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN LOBECTOMY, WHEN ATTEMPTING TO FIRST FIRE ACROSS THE LOBE, THE LOADING UNIT WOULD GO INTO FIRING MODE WITH 2 DIFFERENT RELOADS BUT THE HANDLE WAS NOT ABLE TO FIRE. IT WAS NOTED THAT THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON BUT WAS ABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8303532 ↗
• MalfunctionAug 24, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING ROBOTIC LIVER RESECTION, WHILE STAPLING THE LIVER, AFTER A FEW FIRINGS THE DEVICE WOULD NOT OPEN ONCE PLACED INTO THE PATIENT. TO COMPLETE THE CASE THE SURGEON NEEDED TO PUSH THE CARTRIDGE SIDE AGAINST TISSUE TO MAKE IT OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812688 ↗
• MalfunctionJul 2, 2018Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, WHILE THE STAFF WAS LOADING THE STAPLER, THE DEVICE DID NOT FIRE. THE TECHNICIAN HAD A HARD TIME LOADING AND UNLOADING THE STAPLER AND MAY HAVE BROKEN THE DEVICE DURING ATTEMPTS TO LOAD. THEY OPENED A NEW STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654943 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160176. One submission often covers many models, so check the product and lot details in each record.

• Z-1228-2023 · Jan 25, 2023 · Open, Classified
  Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1237-2018 · Dec 13, 2017 · Terminated
  Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Sta