Signia SIGADAPTSTNDRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,431 adverse event reports that list this exact device (DI 10884521543805), received between Aug 2, 2016 and Sep 29, 2026 — classified as 1 death, 111 injuries, 1,319 malfunctions.

The most frequently reported specific device problem is “Misfire” (422 reports).

14 other recalls cover devices cleared under the same FDA submission (K160176, K201672); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,431 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936651 ↗
• MalfunctionSep 29, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936418 ↗
• MalfunctionSep 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924343 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component; Difficult to Open or Close; Human-Device Interface Problem

  According to the reporter, during a robotic sigmoidectomy for sigmoid resection, and after firing, the reload could not be removed because the jaw would not open, despite the display indicating the device was active and ready, the tissue appeared to be caught at the cartridge tip, interfering with opening and closing, and the cartridge detached while being handled by the nurse. The reporter stated that the firing into tissue was completed without issue and staple formation appeared normal. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850014 ↗
• MalfunctionSep 15, 2026Entrapment of Device; Retraction Problem; Device Displays Incorrect Message

  According to the reporter, during a robotic rectal resection, a yellow error screen was displayed and the adapter was removed and waited until the error display disappeared from the screen, the adapter was then reconnected, but the error was not resolved. The tissue thickness during resection fluctuated between 1 and 2, and after the rectum was resected and the release button was pressed, the knife did not return, so the reload did not open. The monitor then displayed an error instructing removal of the cartridge. The adapter was removed, the error screen cleared, and the adapter was reconnected, but the issue was not resolved. The adapter and handle were then detached and reconnected again without response, and the green buttons were pressed and held for 10 seconds, but the knife still did not return. The articulation returned to straight when the button was pressed, but an attempt to return the knife using the manual adapter tool was unsuccessful because the tool was too hard and became bent. Ultimately, while the bowel remained clamped with the device, one 12 mm port was placed and another device was used to continue the approach, after which resection was completed without furt

  Patient problems: Tissue Breakdown

  MAUDE report 50772861 ↗
• MalfunctionAug 27, 2026Break; Component or Accessory Incompatibility; Human-Device Interface Problem

  According to the reporter, intraoperatively and prior to patient use, the adapter broke. A replacement adapter was obtained, and the issue was resolved without incident. Subsequently, an attempt was made to load a 60 mm reload; however, the reload could not be loaded, possibly due to damage to the adapter's center rod. Additionally, a radial reload was used for the first firing. Following firing, the radial reload was difficult to remove from the device. Although initial removal was challenging, the reload was eventually removed. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50474764 ↗
• InjuryAug 26, 2026Difficult to Remove; Human-Device Interface Problem

  According to the reporter, during a laparoscopic liver resection on the hepatic vein, during removal of the device from the abdominal cavity,  the device did not return to neutral. When there was no other way, it was tried to forcibly removed but the adapter remained partially connected, and the connection part on the cartridge was damaged. The broken part did not fall into the patient's cavity but an x-ray was performed. A new adapter and cartridge were used to complete the case.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 50446892 ↗
• MalfunctionAug 24, 2026Misfire

  According to the reporter, intra-operatively, only some staples were fired and the powered stapler was unable to finish firing the reload. A new reload from the same lot and a manual stapler was used. The new set of stapler completed the firing cycle but was very stiff. The surgical time was extended and the issue caused more tissue resection.

  Patient problems: Tissue Breakdown

  MAUDE report 50399116 ↗
• InjuryAug 18, 2026Entrapment of Device; Calibration Problem

  According to the reporter, during a robot-assisted rectal resection, when at the rectum, when the cartridge was removed, a warning symbol was displayed. The adapter swimlane was black with green outline. It was noted that it was unable to detach the jaw from the tissue. The issue was managed with an electric scalpel, and the procedure was converted to laparotomy in order to take out the cartridge. Also, additional resection was performed on the oral side of the suture site, resulting in a prolonged operative time for more than 30 minutes.

  Patient problems: Laceration(s)

  MAUDE report 50310877 ↗
• MalfunctionAug 14, 2026Entrapment of Device; Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50251345 ↗
• MalfunctionAug 12, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219899 ↗
• MalfunctionAug 12, 2026Entrapment of Device; Human-Device Interface Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50219727 ↗
• MalfunctionAug 10, 2026Misfire

  It was reported that during a laparoscopic sigmoid colon procedure at the sigmoid transection step, the device fired halfway. The surgeon resected and re-stapled to address the intraoperative issue.

  Patient problems: Tissue Breakdown

  MAUDE report 50193795 ↗
• MalfunctionJul 28, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057339 ↗
• MalfunctionJul 6, 2026Unintended System Motion

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD ARTICULATED RIGHT BEFORE THE BLADE STARTED RETRACTING. THERE WERE A POOR STAPLE FORMATION AND BLEEDING. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25715022 ↗
• MalfunctionJun 29, 2026Entrapment of Device

  IT WAS REPORTED THAT, DURING A LUNG SEGMENTECTOMY PROCEDURE, THE RELOAD CONNECTED TO THE ADAPTER BECAME STUCK CLOSED UPON FIRING AND WOULD NOT OPEN, REMAINING LODGED IN THE PATIENT. IT WAS ALSO REPORTED THAT THE THE RELOAD SHAFT BROKE, AND THE BROKEN PART DID NOT DISENGAGE. THE SURGICAL TIME WAS EXTENDED BY 40 MINUTES. THE DEVICES WERE REPLACED WITH ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 25661616 ↗
• MalfunctionJun 17, 2026Misfire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRECTOMY, AT THE TIME OF ESOPHAGOGASTRECTOMY, THE RELOAD PARTIALLY FIRED. THE FIRING STOPPED ABOUT 5MM. FROM THE TIP. IT WAS NOTED THAT THE DOCTOR WAS UNCERTAIN WHETHER IT HAD STOPPED OR IT HAD BEEN PULLED BACK MIDWAY, THINKING IT HAD BEEN FIRED TO THE END. ADDITIONAL RESECTION WAS PERFORMED, AND ADDITIONAL SUTURES WERE PERFORMED WITH A STAPLER.

  Patient problems: Tissue Breakdown

  MAUDE report 25538809 ↗
• MalfunctionJun 14, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY, WHEN ATTEMPTING DUODENECTOMY, THE JAWS WERE UNABLE TO OPEN INSIDE THE ABDOMINAL CAVITY. THE CARTRIDGE WAS FORCIBLY REMOVED, AND A NEW CARTRIDGE WAS CONNECTED TO THE SAME HANDLE AND USED WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25497835 ↗
• MalfunctionMay 14, 2026Misfire

  ACCORDING TO THE REPORTER, IN A SLEEVE GASTRECTOMY, THE POWERED STAPLER ADVANCED HALFWAY, THEN THE FIRING STOPPED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175985 ↗
• MalfunctionMay 4, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER PRESSING THE GREEN BUTTON, THE POWERED STAPLER DID NOT FIRE AND THERE HAD BEEN A PREFIRING. A NEW RELOAD WAS USED BUT THE SAME ISSUE OCCURRED. THE ADAPTER AND THE RELOAD WERE CHANGED, AND THE SURGEON RESET THE HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069097 ↗
• MalfunctionApr 29, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING SETUP, THERE WAS A LOOSE CONNECTION FROM SHELL TO ADAPTER. A NEW ADAPTER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028467 ↗
• MalfunctionApr 27, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC COLECTOMY, DURING INTESTINAL RESECTION, AFTER PERFORMING AN EXTRACORPOREAL RESECTION (A NASTOMOSIS) OF THE INTESTINE, THE SURGEON PRESSED THE UPPER BUTTON ON THE CENTER CONTROL TO OPEN THE TIP OF THE CARTRIDGE, BUT IT FAILED TO OPEN. THE CARTRIDGE FROM THE TISSUE WAS RELEASED, BUT IT REMAINED CLOSED. THE CARTRIDGE WAS REMOVED AND ONLY THE ADAPTER WAS REPLACED WITH A NEW ONE. SUBSEQUENTLY, THE HANDLE COULD BE OPERATED WITHOUT PROBLEMS USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000630 ↗
• MalfunctionApr 11, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC GASTRECTOMY, THE POWERED STAPLER PARTIALLY FIRED FOR ABOUT ONE CM. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851252 ↗
• MalfunctionApr 3, 2026Entrapment of Device; Retraction Problem; Misfire; Calibration Problem; Human-Device Interface Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A LAPAROTOMY LIVER RESECTION, THE FIRST FIRING WENT WELL. THE SECOND RELOAD ADVANCED ONLY HALFWAY AND STOPPED WORKING, RESULTING IN A PARTIAL FIRE. ATTEMPTS TO DEANGULATE AND RETRACT THE RELOAD WERE UNSUCCESSFUL, AND REBOOTING THE POWERED STAPLER MADE A NOISE BUT DID NOT REALIGN OR RETRACT THE RELOAD. THE RELOAD APPEARED BROKEN AT THE ARTICULATION JUNCTION. THE LIGHT-EMITTING DIODE (LED) SCREEN SHOWING A YELLOW ARROW TO THE RIGHT. THE SCRUB NURSE CONFIRMED THAT ATTACHING AND TESTING THE CONNECTION WAS PERFORMED AS USUAL, AND THE SURGEON WAS ABLE TO PRESS THE ACTIVATION BUTTON AND ACTIVATE THE DEVICE AS USUAL. THE SURGEON DID NOT CHECK THE LED SCREEN FOR TISSUE THICKNESS. TO RESOLVE THE ISSUE, THE SURGEON CUT AROUND THE LIVER TO REMOVE THE STUCK RELOAD, OPENED A MANUAL STAPLER AND A NEW RELOAD, AND USED CLIPS AND SUTURES AS NEEDED TO COMPLETE THE PROCEDURE. THE NURSE WAS UNABLE TO REMOVE THE RELOAD FROM THE ADAPTER DUE TO PERSISTENT ANGULATION.

  Patient problems: Tissue Breakdown

  MAUDE report 24780879 ↗
• MalfunctionApr 1, 2026Retraction Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY TO CUT THE APPENDIX, THE RELOAD FIRED COMPLETELY BUT WOULD NOT RETRACT THE KNIFE BLADE. STAFF REPORTEDLY CRANKED THE SCREWDRIVER THE WRONG WAY FOR A LONG TIME WHILE TRYING TO DETERMINE WHAT TO DO, AND THE PROCEDURE WAS EXTENDED BY ABOUT 30 MINUTES. A MANUAL RETRACTION TOOL WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760850 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160176, K201672. 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-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• 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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• 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