Signia SIGADAPTXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 452 adverse event reports that list this exact device (DI 10884521543812), received between Sep 6, 2017 and Sep 24, 2026 — classified as 57 injuries, 395 malfunctions.

The most frequently reported specific device problem is “Misfire” (156 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 452 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Misfire

  It was reported that during a gastric bypass procedure, the surgeon positioned the stapler on the tissue to create the gastric pouch. Upon the third firing, after noting that the indicator read "1", the surgeon began to fire, but midway through the firing, the tissue began to bunch up, the staples started to deform, and the blade failed to advance. The issue was managed by resecting and re-stapling the tissue.

  Patient problems: Tissue Breakdown

  MAUDE report 50877034 ↗
• MalfunctionSep 22, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860149 ↗
• MalfunctionSep 21, 2026Entrapment of Device; Retraction Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50847087 ↗
• MalfunctionSep 21, 2026Break; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844323 ↗
• MalfunctionAug 3, 2026Entrapment of Device; Retraction Problem; Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50111721 ↗
• 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 25209791 ↗
• MalfunctionApr 23, 2026Misfire

  IT WAS REPORTED THAT, DURING THE MINI GASTRIC BYPASS, THE TWO RELOADS WERE NOT ABLE TO FIRE FULLY, HALF OF PINS COMES OUT AND HALF OF PINS WERE REMAINING INSIDE. THE PROCEDURE WAS EXTENDED BY 2 HOURS AS A RESULT. ANOTHER COMPANY PRODUCT WAS USED TO COMPLETE THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24972562 ↗
• MalfunctionApr 16, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE JAWS OF THE RELOAD DID NOT CLOSE COMPLETELY. THE DEVICE WAS REPLACED WITH ANOTHER STANDARD ADAPTER USING THE SAME RELOAD, WHICH CLOSED CORRECTLY WITH THE NEW ADAPTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901853 ↗
• MalfunctionApr 16, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD FIRED HALFWAY, LEAVING ONE-THIRD OF THE STAPLE LINE UNFINISHED. A NEW REINFORCED RELOAD WAS USED WITH THE SAME POWERED HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894263 ↗
• MalfunctionApr 14, 2026Entrapment of Device; Difficult to Remove; Retraction Problem; Device Displays Incorrect Message; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN (HPB) HEPATOBILIOPANCREATIC, DISTAL PANCREATECTOMY AND SPLENECTOMY SURGICAL PROCEDURE, AN UNDEFINED ADAPTER ERROR, ISSUES AFTER FIRING, AND DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT. THE YELLOW CAUTION ERROR APPEARED ON THE SCREEN WITH AN ADAPTER ERROR AND AN ARROW INDICATING TO REMOVE THE RELOAD WHILE THE DEVICE WAS STILL CLAMPED ON TISSUE. THIS OCCURRED DURING FIRING WHILE ATTEMPTING TO RETRACT THE KNIFE BLADE, WHICH MOVED FORWARD AND BACKWARD ABOUT 2 CM. DISCONNECTING THE HANDLE DID NOT RESOLVE THE ISSUE. A RESET OF THE POWER HANDLE ULTIMATELY ALLOWED RETRACTION OF THE KNIFE BLADE AND REMOVAL OF THE STAPLER FROM THE TISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FROM SR-609032065- DUPLICATE OF PE 709009542.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871420 ↗
• MalfunctionMar 30, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE POWERED STAPLER WAS NOT FULLY FIRED. THE STAPLER STOPPED AFTER 2 CM AND WOULD NOT CONTINUE FIRING. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712285 ↗
• MalfunctionMar 20, 2026Failure to Read Input Signal; Vibration; Unintended Movement

  IT WAS REPORTED THAT PRE-OPERATIVELY, WHILE ON PREPARATION FOR USE, THE ADAPTER DID NOT TAKE THE RELOAD, AND AFTER A NEW RELOAD WAS INSERTED, THE DEVICE STARTED TWITCHING AND THE GUIDE ROD BEGAN MOVING OUT ON ITS OWN. THE ADAPTER STILL HAD 43 LIVES LEFT TO USE. ASECOND ADAPTER HAD TO BE ATTACHED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24654826 ↗
• InjuryMar 20, 2026Misfire

  IT WAS REPORTED THAT DURING A VERTICAL SLEEVE GASTRECTOMY, THE LAST TWO SHOTS USING THE SAME SHELL MALFUNCTIONED, MAKING IT IMPOSSIBLE TO PROPERLY COMPLETE THE STAPLING STAGE; THE FIRING STOPPED. AFTER PERFORMING THE METHYLENE BLUE TEST, EVIDENCE OF FLUID LEAKAGE WAS OBSERVED THROUGH A HOLE OF APPROXIMATELY 3 CM IN THE STAPLE LINE. DUE TO THIS FINDING, THE PROCEDURE WAS CONVERTED TO A GASTRICBYPASS TO ENABLE ADEQUATE CORRECTION AND SAFE COMPLETION OF THE SURGERY.

  Patient problems: Tissue Breakdown

  MAUDE report 24654809 ↗
• 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 24637411 ↗
• 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 24637386 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC BAND REMOVAL AND SLEEVE GASTRECTOMY, WHEN STAPLING THE STOMACH, THE RELOAD AND ADAPTER WERE BOTH BROKEN AT THE CONNECTION BETWEEN THE RELOAD AND ADAPTER THUS UNABLE TO FIRE. THE SURGEON NOTED THAT SIGNIFICANT TENSION WAS APPLIED TO THE ADAPTER AND RELOAD TO POSITION THE RELOAD AROUND THE TISSUE, WHICH RESULTED IN THE BREAKAGE. THE DEVICES WERE REPLACED WITH NEW ADAPTER AND RELOAD AND THE PROCEDURE WAS COMPLETED. THE REPRESENTATIVE TRIED TO REMOVE THE RELOAD FROM THE ADAPTER, BUT THE CONNECTION BETWEEN THE TWO WAS DAMAGED TO THE POINT THAT THE RELOAD COULD NOT BE REMOVED WITHOUT A PORTION OF THE RELOAD REMAINING IN THE ADAPTER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491087 ↗
• MalfunctionFeb 25, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING SURGERY, SURGEONS WERE UNABLE TO OPEN THE STAPLER CLAMPED ONTO TISSUE. ATTEMPTS TO RESOLVE THE SITUATION INCLUDED RESTARTING THE STAPLER, CHANGING THE SHELL OR HANDLE, AND PERFORMING A MANUAL EMERGENCY OPENING PROCEDURE, ALL OF WHICH WERE UNSUCCESSFUL. RESISTANCE WAS ENCOUNTERED DURING THE MANUAL OPENING ATTEMPT, AND THE STAPLER WAS ULTIMATELY FORCIBLY REMOVED FROM THE PATIENT. ADDITIONAL SUTURING WAS PERFORMED AT THE SITE OF REMOVAL AS STAPLE LINE REINFORCEMENT. THE SURGICAL TIME WAS EXTENDED BY 30-35 MINUTES DUE TO THE DEVICE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24444348 ↗
• MalfunctionFeb 16, 2026Break; Detachment of Device or Device Component; Difficult to Open or Close; Human-Device Interface Problem; Unintended Movement

  IT WAS REPORTED THAT DURING AN OPERATION, THE ADAPTER COULD BE FIRED WITH TWO RELOADS; HOWEVER, WITH THE THIRD MAGAZINE, THE RELOAD JAWS WOULD NOT OPEN AND CLOSE. INSTEAD, THE MAGAZINE ANGLED AND STRAIGHTENED. ATTEMPTS TO CHANGE THE RELOAD WERE UNSUCCESSFUL, AS THE RELOAD COULD NOT BE DISCONNECTED FROM THE ADAPTER AND ULTIMATELY BROKE OFF. THE OPERATION WAS CONTINUED USING A NEW ADAPTER AND A NEW MAGAZINE. THE SAME HANDLE WORKED FINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24355388 ↗
• MalfunctionFeb 12, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE POWERED HANDLE LOCKED ON TISSUE AND COULD NOT BE REMOVED, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 45 MINUTES. THE DEVICE WAS REPLACED BY CHANGING TO ANOTHER HANDLE, ADAPTER, AND RELOAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24323209 ↗
• MalfunctionFeb 4, 2026Entrapment of Device; Retraction Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING THE GASTRIC BYPASS SURGERY, UPON INITIATING THE FIRING, THE SURGEON HEARD A STRANGE NOISE. ONCE THE FIRING BEGAN AND ENDED, THE RELOAD REMAINED EMBEDDED IN THE TISSUE. IT DID NOT RETRACT OR OPEN FOR REMOVAL. THE ADAPTER WAS DISCONNECTED FROM THE POWERED STAPLER, AND A MANUAL RETRACTION TOOL WAS USED. AN ATTEMPT WAS MADE TO OPEN THE RELOAD, BUT IT ALSO FAILED. IT WAS FEASIBLE; ATTEMPTS WERE MADE WITH THE THREE MANUAL OPERATING SITES, BUT NONE RESPOND. THE SURGEON RECONNECTED THE POWERED STAPLER TO THE ADAPTER, AND IT SUCCESSFULLY RECOGNIZED THE RELOAD, ALLOWING IT TO BE OPENED AND REMOVED WITH THE POWERED STAPLER. NO RELOAD, ADAPTER, OR HANDLE ERROR WAS DISPLAYED ON THE DEVICE. IT WAS ALSO NOTED THAT THE TRI-STAPLE LINE WAS NOT FORMED, AND UNEVEN FIRING MARKS WERE OBSERVED. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH ANOTHER RELOAD FROM THE SAME LOT.

  Patient problems: Tissue Breakdown

  MAUDE report 24264519 ↗
• MalfunctionJan 29, 2026Entrapment of Device; Retraction Problem

  IT WAS REPORTED THAT DURING A VERTICAL GASTRECTOMY, THE RELOAD LOCKED ON TISSUE AND COULD NOT BE REMOVED AFTER FIRING. THE SCALPEL FAILED TO RETRACT, THE RELOAD BECAME JAMMED, AND THE RETRACTION KEY BROKE. THE CONTROLS ON THE POWER HANDLE DID NOT WORK TO OPEN THE STAPLE AFTER FIRING THE RELOAD, AND THE MANUAL RETRACT TOOL BROKE. THE SURGEON SLOWLY SLID THE TISSUE BACK INTO PLACE, RELEASING THE RELOAD, AND REINFORCED THE AREA WITH AN ABSORBABLE, MONOFILAMENT SUTURE, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 20 MINUTES. THE SURGERY CONTINUED AFTER THE EQUIPMENT WAS REPLACED.

  Patient problems: Tissue Breakdown

  MAUDE report 24216236 ↗
• MalfunctionJan 22, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A ROUX-EN-Y GASTRIC BYPASS, THE FIRST RELOAD FIRED APPROPRIATELY FOR THE POUCH. THE SECOND RELOAD FIRED APPROPRIATELY FOR 2 CM AND STOPPED, THEN SURGED FORWARD IN JERKY MOTION FOR THE NEXT 4 CM. THE SURGEON KEPT THE TRIGGER DEPRESSED THE ENTIRE TIME. AFTER RETRACTING THE BLADE, THE TISSUE ON THE FIRST 2 CM WAS SATISFACTORY, BUT THE REMAINDER OF THE LINE HAD BEEN CUT FOR 4 CM BUT NOT STAPLED. IT APPEARED THAT THIS TISSUE HAD BEEN TORN AND/OR CUT, OR THE ISSUE WAS CAUSED BY A STAPLE DRAGGED BY AN I-BEAM. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THE POUCH WAS MADE A LITTLE TIGHTER.

  Patient problems: Tissue Breakdown

  MAUDE report 24152470 ↗
• MalfunctionJan 9, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PULMONARY SEGMENTECTOMY, THE POWERED STAPLER STOPPED MID-FIRE, FAILING TO FULLY STAPLE THE TISSUE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020411 ↗
• MalfunctionJan 8, 2026Unintended Movement; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE HANDLE, ADAPTER, AND RELOAD UNIT BEGAN ROTATING ON ITS OWN. STAFF DISASSEMBLED THE ENTIRE UNIT BUT WERE UNABLE TO DETERMINE WHICH COMPONENT WAS DEFECTIVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24002671 ↗
• MalfunctionJan 8, 2026Unintended Movement

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC BYPASS, THE POWERED STAPLER WAS ROTATING ON ITS OWN. THE STAFF DISASSEMBLED THE ENTIRE UNIT BUT WAS UNABLE TO PINPOINT WHICH COMPONENT WAS DEFECTIVE. THE HANDLE, ADAPTER AND RELOAD WERE REPLACED 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 24002334 ↗

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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• 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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• 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