Signia SIGPSHELLRecalls & reported problems

Summary

The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 10884521543799), received between May 30, 2017 and Sep 21, 2026 — classified as 1 death, 8 injuries, 218 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (68 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 227 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Unraveled Material

  It was reported that during a procedure, the control shell could not close as expected. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839526 ↗
• MalfunctionSep 21, 2026Unraveled Material

  It was reported that during a procedure, the power control shell could not be locked. A new shell 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 50836281 ↗
• MalfunctionAug 26, 2026Human-Device Interface Problem

  It was reported that during a rectotomy, while on high anterior resection, after the firing, the jaw opened fully; however, the cart ridge did not return to the neutral position, even when the up button on the center control was long-pressed or the left/right buttons were pressed. Manual adapter tools were used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446981 ↗
• MalfunctionAug 12, 2026Unraveled Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219064 ↗
• MalfunctionJun 4, 2026Unraveled Material

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX-EN-Y DIVIDED GASTRIC BYPASS AND LAPAROSCOPIC HIATAL HERNIA REPAIR, THE SHELL WOULD NOT LOCK.

  Patient problems: Insufficient Information

  MAUDE report 25403146 ↗
• MalfunctionMay 18, 2026Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE BUT PRIOR TO PATIENT CONTACT, A LOOSE CONNECTION FROM THE SHELL TO THE ADAPTER WERE OBSERVED AND THE ADAPTER WAS DISCONNECTED FROM THE SHELL AND RECONNECTED, AND THE CARTRIDGE WAS DISCONNECTED AND RECONNECTED, AFTER WHICH THE SYSTEM WORKED AGAIN. LATER IN THE PROCEDURE, THE ADAPTER FELL OFF THE SHELL AND WAS RECONNECTED AGAIN, AND IT THEN WORKED FOR THE REMAINDER OF THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209810 ↗
• MalfunctionApr 6, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PREOPERATIVELY, LOOSE CONNECTION FROM SHELL TO ADAPTER. A NEW SHELL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795829 ↗
• MalfunctionApr 6, 2026Unraveled Material

  IT WAS REPORTED THAT PREOPERATIVELY, THE SHELL DID NOT CLOSE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792460 ↗
• MalfunctionMar 31, 2026Difficult to Insert; Unraveled Material

  IT WAS REPORTED THAT DURING SET-UP PRIOR TO PATIENT CONTACT WITH THE POWERED SHELL, THE INSERTION GUIDE DID NOT FIT AND THE POWER SHELL COULD NOT BE CLOSED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738219 ↗
• MalfunctionMar 19, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A GASTROPLASTY, THE ADAPTER CAME LOOSE WHILE THE DOCTOR WAS POSITIONING THE LOAD FOR STAPLING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637418 ↗
• MalfunctionMar 19, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A GASTROPLASTY, THE ADAPTER CAME LOOSE WHILE THE DOCTOR WAS POSITIONING THE LOAD FOR STAPLING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637395 ↗
• MalfunctionMar 11, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PARTIAL PULMONARY RESECTION, ON ASSEMBLY, WHEN THE USER TRIED TO TAKE THE DEVICE OUT OF THE BLISTER PACK, IT WAS TAKEN OUT FROM THE PACK AS USUAL, AND THE SHELL BROKE INTO TWO. THE USER TOOK IT OUT WITH BOTH HANDS, SO NO STRONG FORCE WAS APPLIED. ANOTHER SHELL WAS USED AS SUBSTITUTE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575233 ↗
• MalfunctionMar 2, 2026Imprecision; Unraveled Material

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE ENGAGEMENT OF THE SHELL TO THE POWERED HANDLE WAS STRANGE/IMPROPER AND THE SHELL COULD NOT BE CLOSED. A NEW POWERED SHELL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24478528 ↗
• MalfunctionFeb 17, 2026Unraveled Material

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SHELL WAS UNABLE TO CLOSE AS EXPECTED. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369538 ↗
• MalfunctionFeb 3, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A SINGLE PORT VIDEO-ASSISTED THORACOSCOPIC FOR PERIPHERAL LUNG LESIONS (VATS-PLL) LOBECTOMY, THE ADAPTER DETACHED FROM THE SHELL WITHOUT EXTERNAL FORCE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24255091 ↗
• MalfunctionJan 29, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE ADAPTER DOES NOT SEAT PROPERLY INTO THE CLAMSHELL. THE CONNECTION IS LOOSE. A NEW SHELL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24217058 ↗
• MalfunctionJan 22, 2026Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY, DURING SETUP, THE ADAPTER GO SEPARATED FROM THE SHELL PRIOR TO FIRING. A MANUAL STAPLER WITH THE SAME RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152939 ↗
• MalfunctionJan 16, 2026Unraveled Material

  ACCORDING TO THE REPORTER, THE ISSUE OF BEING UNABLE TO CLOSE POWERSHELL WAS ENCOUNTERED PREOPERATIVELY. A NEW SHELL WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093150 ↗
• MalfunctionJan 7, 2026Device Difficult to Setup or Prepare; Insufficient Device Problem Information

  IT WAS REPORTED THAT PREOPERATIVELY, WHILE ON SET-UP, THE ADAPTER WAS AUTOMATICALLY CONNECTING AND DISCONNECTING TO THE POWER SHELL REPEATEDLY, AND THERE WAS A LOOSE CONNECTION FROM THE SHELL TO THE ADAPTER. A NEW SHELL 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 23998211 ↗
• MalfunctionDec 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN ON FIRING AT THE RECTAL RESECTION, THE KNIFE WAS PULLED BACK ON ITS OWN WITHOUT COMPLETING THE FIRING. IT WAS CONFIRMED THAT THE CONNECTION PART OF THE ADAPTER AND THE SHELL WAS LOOSE. THE COMPONENTS WERE REATTACHED AS IT WAS. ADDITIONAL RESECTION WAS PERFORMED, AND ADDITIONAL SUTURING WAS DONE WITH A STAPLER TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23918763 ↗
• MalfunctionDec 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A S6 SEGMENTAL RESECTION BUT BEFORE USING IT ON THE PATIENT, THE POWERED STAPLER WAS HANDED TO THE PHYSICIAN FROM THE SCRUB NURSE, THE ADAPTER SUDDENLY FELL OFF FROM THE SHELL. TO RESOLVE THE ISSUE, IT WAS RE-ATTACHED EVERYTHING AGAIN AND USED IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892127 ↗
• MalfunctionDec 17, 2025Connection Problem

  POWER SHELL NOT CONNECTING WITH BATTERY, HAD TO SWITCH SHELLS TO WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827470 ↗
• MalfunctionDec 8, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, BEFORE USE, THE POWER SHELL CANNOT BE CLOSED. ANOTHER HANDLE AND A NEW SHELL WERE TAKEN OUT AND USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744116 ↗
• MalfunctionOct 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPIC PULMONARY RESECTION, DESPITE THE ADAPTER PROPERLY CONNECTED UNTIL IT CLICKED, IT DETACHED FROM THE SHELL DURING THE APPROACH. THERE WERE NO ERROR MESSAGES ON THE DISPLAY, ALL GREEN DISPLAY. THE ADAPTER AND SHELL WERE EACH REPLACED WITH NEW ONES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367864 ↗
• MalfunctionOct 22, 2025Break; Device Displays Incorrect Message; Break; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN ASSEMBLING THE ROD IN THE STAPLER, THE ADAPTER DISPLAYED A YELLOW SWIMLANE ERROR ON THE SCREEN. ADDITIONALLY, THE SHELL WAS REPORTED TO HAVE DAMAGE TO THE SHAFT, WHICH ALSO PREVENTED USE OF THE STAPLER. BOTH DEVICES WERE REPLACED WITH A STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357157 ↗

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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• 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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• 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