Signia SIGLU60ARecalls & reported problems
Covidien LP · Loading Unit · Class 2
All models of Signia (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Signia SIGLU60A loading unit for implantable staples is used with a powered stapler. Most reports describe it failing to fire or form staples, sometimes leaving staples in the body or causing bleeding and extended surgical time. 80 reports mention it, with no deaths and 25 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10884521543508), received between Aug 23, 2017 and Sep 21, 2026 — classified as 25 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (21 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Fire21
- Failure to Form Staple15
- Adverse Event Without Identified Device or Use Problem12
- Misfire12
- Break10
- Human-Device Interface Problem10
- Difficult to Open or Close9
- Entrapment of Device7
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Code Available15
- No Known Impact Or Consequence To Patient13
- No Consequences Or Impact To Patient11
- Unspecified Tissue Injury9
- Hemorrhage/Blood Loss/Bleeding6
- Tissue Damage5
- Blood Loss4
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Entrapment of Device; Retraction Problem
It was reported that during gastrojejunostomy, after firing the device on gastrojejunostomy tissue, the knife became locked and could not be retracted. The reload was locked on tissue and could not be removed after firing. The surgeon resected the stapler line, and the gastrojejunostomy tissue/staple line was sutured as a staple-line replacement. No patient complications have been reported as a result of this event.
Patient problems: Tissue Breakdown
MAUDE report 50841344 ↗MalfunctionFeb 2, 2026Misfire; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE LOADING UNITS AND RELOADS WITH A POWERED STAPLER AND XL ADAPTER, THE RELOADS WERE NOT ABLE TO FORM PROPER B STAPLES, STAPLES THAT OPENED AND COULD NOT CLOSE FULLY, STAPLES FELL INTO THE ABDOMINAL CAVITY, RELOADS WERE NOT ABLE TO FIRE FULLY, INCOMPLETE STAPLE LINES, AND THE DEVICE NOT BEING ABLE TO FIRE EVEN WITH NEW BLADES AND RELOADS WHICH RESULTED TO EXTENDED SURGICAL TIME OF TWO HOURS DUE TO MULTIPLE DEVICE ISSUES. IT WAS CONFIRMED THAT THE STAPLES WERE RETRIEVED BY HAND INSTRUMENTS. TROUBLESHOOTING INVOLVED REPLACING THE DEVICE WITH NEW BLADES AND RELOADS, BUT THE SAME ISSUES PERSISTED, LEADING TO THE USE OF STAPLERS FROM ANOTHER COMPANY.
Patient problems: Tissue Breakdown
MAUDE report 24242768 ↗MalfunctionFeb 2, 2026Misfire; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE LOADING UNITS AND RELOADS WITH A POWERED STAPLER AND XL ADAPTER, THE RELOADS WERE NOT ABLE TO FORM PROPER B STAPLES, STAPLES THAT OPENED AND COULD NOT CLOSE FULLY, STAPLES FELL INTO THE ABDOMINAL CAVITY, RELOADS WERE NOT ABLE TO FIRE FULLY, INCOMPLETE STAPLE LINES, AND THE DEVICE NOT BEING ABLE TO FIRE EVEN WITH NEW BLADES AND RELOADS WHICH RESULTED TO EXTENDED SURGICAL TIME OF TWO HOURS DUE TO MULTIPLE DEVICE ISSUES. IT WAS CONFIRMED THAT THE STAPLES WERE RETRIEVED BY HAND INSTRUMENTS. TROUBLESHOOTING INVOLVED REPLACING THE DEVICE WITH NEW BLADES AND RELOADS, BUT THE SAME ISSUES PERSISTED, LEADING TO THE USE OF STAPLERS FROM ANOTHER COMPANY.
Patient problems: Tissue Breakdown
MAUDE report 24242750 ↗MalfunctionJan 29, 2026Failure to Read Input Signal; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, AN ISSUE OCCURRED WHILE ATTEMPTING TO TRANSECT THE DUODENUM. THE USER FIRST REPLACED THE POWER HANDLE AND SHELL, THEN TRIED USING THE ORIGINAL LOADING UNIT. HOWEVER, THE STAPLER FAILED TO FIRE THERELOAD, THE LOADING UNIT DID NOT RECOGNIZE. SUBSEQUENTLY, THE STAFF REPLACED THE LOADING UNIT WITH THE ORIGINAL STAPLE CARTRIDGE. THIS EXTENDED THE SURGICAL TIME BY A FEW MINUTES. THE LOADING UNIT AND CARTRIDGE WERE RECOGNIZED BY THE STAPLER, AND THE SURGEON WAS ABLE TO FIRE THE DEVICE SUCCESSFULLY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24215779 ↗MalfunctionJul 14, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
IT WAS REPORTED THAT DURING THE USE OF THE CARTRIDGE, THERE WERE FIRING ISSUES WITH THE RELOAD, IMPROPER B STAPLE FORMATION, AND AN INCOMPLETE STAPLE LINE AT THE DISTAL END. ADDITIONALLY, THERE WAS BLEEDING ALONG THE STAPLE LINE AFTER COMPLETE FIRING. THE RESOLUTION REQUIRED RESECTION AND RE-STAPLING. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE DAMAGED LOADING UNIT ADAPTER WAS DUE TO OVER FLEXURE OF THE LOADING UNIT WHILE ATTACHED TO THE INSTRUMENT.
Patient problems: Insufficient Information
MAUDE report 22500326 ↗MalfunctionApr 21, 2023Failure to Read Input Signal; Difficult to Open or Close; Failure to Read Input Signal; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC COLECTOMY, WHEN LOADING THE STAPLER, THE JAWS CLOSED BUT THE STAPLER WOULD NOT RE COGNIZED THE LOADING UNIT AND THE JAWS WOULD NOT RE-OPEN. USED ANOTHER LOADING UNIT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16788980 ↗MalfunctionApr 13, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, PRIOR TO FIRING, THE FIRST CARTRIDGE ATTACHED TO THE LOADING UNIT WOULD ONLY ARTICULATE ABOUT 15-20 DEGREES. ANOTHER LOADING UNIT AND CARTRIDGE WERE USED NEXT BUT STAPLER STOPPED FIRING HALFWAY THROUGH WHILE THERE WAS NO EXCESSIVE FORCE SIGNAL. THE HANDLE STILL SHOWED ZONES 1-3 AND IT WOULD NOT MOVE FORWARD AT ALL. SURGEON RETRACTED THE DEVICE AND USED A SINGLE-USE RELOAD TO CONTINUE THE CASE.
Patient problems: Unspecified Tissue Injury
MAUDE report 16737928 ↗MalfunctionMar 21, 2023Break; Detachment of Device or Device Component; Human-Device Interface Problem; Break; Detachment of Device or Device Component; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IN THE STOMACH, WHILE ATTACHING THE RELOAD TO THE HANDLE, THE BLACK END PART OF THE RELOAD BROKE OFF, HENCE THE DEVICE COULD NOT BE FIRED. THIS CAUSES DIFFICULTY IN UNLOADING THE DEVICE. A NEW RELOAD OF THE SAME TYPE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16588187 ↗MalfunctionMar 10, 2023Human-Device Interface Problem; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, AT THE TIME OF TRANSECTING THE STOMACH, THE SURGEON W AS UNABLE TO PRESS THE GREEN BUTTON; THEREFORE, THE DEVICE DID NOT FIRE. THE DEVICE WAS UNABLE TO ARTICULATE. TROUBLESHOOTING STEPS WERE PERFORMED AND A MANUAL RETRACTION TOOL WAS USED TO STRAIGHTEN THE RELOAD TO BE REMOVED FROM THE BODY CAVITY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16521302 ↗InjuryOct 7, 2022Misfire; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Misfire; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHEN STAPLING THE STOMACH, THE STOMACH WAS PULLED BY THE KNIFE. THE STAPLES WERE NOT FULLY FORMED AND THE STOMACH STARTED BLEEDING. THE STAPLE LINE WAS INCOMPLETE CENTRALLY. THE SURGEON USED MANY SUTURES TO STOP THE BLEEDING. ANOTHER RELOAD WAS OPENED TO RESOLVE THE ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 15567208 ↗MalfunctionOct 3, 2022Misfire; Misfire
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ONE ANASTOMOSIS GASTRIC BYPASS, AFTER THE MOBILIZATION, THE SURGEON STARTED THE FIRST FIRING. THE FIRST SQUEEZE WAS DONE, HOWEVER, AFTER THAT FIRING WOULD NOT PROCEED. THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE BECAUSE IT WAS TIGHT. SECOND CARTRIDGE WAS TAKEN OUT FOR FIRING, THE SAME THING HAPPENED. THEN, THE SURGEON CHANGE BOTH THE HANDLE AND THE RELOAD TO A PURPLE 60MM ARTICULATING TRI-STAPLE RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. AFTER THE CASE, THE DOCTOR CHECKED THE FIRST HANDLE AND IT WAS WORKING FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15532074 ↗InjuryJun 27, 2022Misfire; Failure to Form Staple; Misfire; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE STAPLING STOMACH, THE KNIFE DID CUT IN THE BEGINNING WITHOUT STAPLING. THEN, CUTTING AND STAPLING STOPPED, SO THERE WAS A HUGE TISSUE DAMAGE, TISSUE LOSS, AND BLEEDING. THE STAPLE LINE WAS INCOMPLETE AT THE DISTAL. A NEW RELOAD WAS OPENED, AND THE SURGEON STAPLED NEAR THE DAMAGED STAPLE LINE TO CLOSE IT AND STOP BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 14836790 ↗MalfunctionApr 27, 2022Entrapment of Device; Entrapment of Device
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY FOR OBESITY, AFTER FIRING THE SIXTH RELOAD TO CUT THE STOMACH, THE JAWS OF THE DEVICE LOCKED ON TISSUE IN THE MID SECTION. THE DEVICE WAS REMOVED. ANOTHER RELOAD OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219829 ↗MalfunctionMar 18, 2022Failure to Read Input Signal; Failure to Form Staple; Device Displays Incorrect Message; Failure to Read Input Signal; Failure to Form Staple; Device Displays Incorrect Message
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE TRANSECTING THE STOMACH, THE STAPLE LINE WAS IN COMPLETE, AND THERE WAS A BLACK DOT THAT APPEARED IN RELOAD LANE ON SCREEN DURING FIRING. THE SECOND RELOAD APPEARED WITH BLACK DOT ALSO. THE LOADING UNIT WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13804510 ↗MalfunctionMar 18, 2022Failure to Read Input Signal; Failure to Form Staple; Failure to Read Input Signal; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHILE TRANSECTING THE STOMACH, THE STAPLE LINE WAS IN COMPLETE, AND THERE WAS A BLACK DOT THAT APPEARED IN RELOAD LANE ON SCREEN DURING FIRING. THE LOADING UNIT WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13803965 ↗MalfunctionMar 17, 2022Failure to Read Input Signal; Failure to Fire; Failure to Read Input Signal; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN LOADING UNIT WAS BEING ADDED TO ADAPTER PRIOR TO TRANSECTION OF STOMACH, THE RELOAD NOT RECOGNIZED. THE LOADING UNIT IS REPLACED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13802802 ↗MalfunctionMar 16, 2022Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE TRANSECTING THE STOMACH, THE CLAMP TEST WAS SUCCESSFUL AND ALL INDICATORS WERE GREEN. HOWEVER, WHEN THE JAWS WERE CLOSED ON THE TISSUE, THE GREEN BUTTON DID NOT LIGHT UP AND THE USER WAS NOT ABLE TO FIRE THE DEVICE. THE CARTRIDGE WAS REPLACED BUT THE GREEN BUTTON STILL DID NOT LIGHT UP. THE ADAPTER WAS REPLACED NEXT BUT THE SAME ISSUE HAPPENED. FINALLY, THE LOADING UNIT WAS REPLACED AND WAS USED WITH THE SAME ADAPTER AND CARTRIDGE, THE SURGERY WAS COMPLETED WITH NO PROBLEM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13790237 ↗MalfunctionMar 14, 2022Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WAS NO ISSUE WITH LOADING THE LOAD TO THE STAPLER BUT STAPLER HANDLE WAS NOT ABLE TO BE SQUEEZED AND THE GREEN BUTTON COULD NOT BE PRESSED. THE LOADING UNIT IS REPLACED IN ORDER TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13755699 ↗MalfunctionMar 2, 2022Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN STAPLING THE STOMACH, THE DEVICE WAS UNABLE TO FIRE - GREEN BUTTON COULD NOT BE PRESSED. A NEW DEVICE WAS OPENED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13654912 ↗InjuryDec 28, 2021Misfire; Misfire
ACCORDING TO THE REPORTER DURING THE REVISION OF GASTRIC BYPASS VIA LAPAROSCOPIC PROCEDURE WHILE ON THE FIRST 2 FIRINGS OF THE STAPLER ON THE STOMACH POUCH, WHEN ATTEMPTING TO TRANSECT THE "CANDY CANE" REMNANT POUCH, A STAPLE LINE FAILURE ON THE CENTRAL AREA OCCURRED. THE SIDE MEDIAL TO THE TRANSECTION THE STAPLE LINE NEVER FORMED AND THE STAPLES NEVER FORMED B-SHAPES. THE STAPLE LINE WAS NOT COMPLETED IN A CRUCIAL PART OF THE PROXIMAL STOMACH POUCH ANATOMY. BECAUSE OF THIS. THE SURGEON FUTURE MOBILIZE THE ESOPHAGUS AND CREATE A LINEAR ANASTOMOSIS CONNECTION THE JEJUNUM TO THE PROXIMAL POUCH. THIS WAS NOT THE DESIRED PROCEDURAL SOLUTION. STAPLE LINE WAS FIXED BY OVER SEWING USING A BARBED SUTURE. THE SURGICAL INTERVENTION AND SOLUTION INVOLVED TISSUE THAT WAS NOT INTENDED ON THE GAME PLAN FOR THE PROCEDURE WHICH CAUSED PERMANENT DAMAGE. THERE WAS EXTENDED SURGICAL TIME OF 30 MINUTES OR MORE.
Patient problems: Unspecified Tissue Injury
MAUDE report 13096771 ↗MalfunctionDec 1, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y, WHILE PERFORMING A SMALL BOWEL ANASTOMOSIS, THE DEVICE ENTERED FIRING MODE BUT DID NOT FIRE ON FIVE CARTRIDGE'S. ON THE LAST SIXTY MILLIMETER LOADING UNIT, THE SURGEON WAS NOT ABLE TO SQUEEZED THE HANDLE AFTER PRESSING THE GREEN BUTTON. TO RESOLVE THE ISSUE, THE SURGEON USED A COMPETITOR'S DEVICE. THE SURGERY GOT EXTENDED FOR THIRTY MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12913848 ↗MalfunctionOct 26, 2021Failure to Fire; Detachment of Device or Device Component; Human-Device Interface Problem; Failure to Fire; Detachment of Device or Device Component; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINI GASTRIC BYPASS, ON THE STOMACH FOR POUCH PREPARATION, AFTER LOADING THE CARTRIDGE IN THE MULTI USE LOADING UNIT (MULU), WHEN THE SURGEON TRIED TO FIRE THE DEVICE, THE STAPLER DID NOT FIRE, AND THE DOCTOR WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. THE DISTAL PART OF THE MULU BROKE OFF AND PART OF THE LOADING UNIT WAS STUCK IN THE STAPLER. WHEN THE CARTRIDGE WAS NOT FIRED, THE SURGEON HAS TAKEN OUT HANDLE AND UNLOAD THE LOADING UNIT FROM HANDLE. AT THAT TIME, THE LOADING UNIT WAS FOUND BROKEN. A NEW HANDLE AND RELOAD WERE UTILIZED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12700865 ↗MalfunctionOct 13, 2021Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING STOMACH STAPLING ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE STAPLER FIRED BUT THE STAPLE LINE FROM 4 RELOADS WERE NOT ALIGNED AND THE STAPLES WERE RANDOMLY FORMED. THE STAPLES WERE NOT STRONGLY ATTACHED TO THE TISSUES. NEW DEVICES WERE USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12629077 ↗InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, HOURS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY, PATIENT HAD TO BE TAKEN BACK TO SURGERY FOR AN ADDITIONAL HOUR PROCEDURE TO CONTROL BLEEDING STAPLE LINES. SURGEON HAD TO OVER SEW THE STAPLE LINES AND A BLOOD TRANSFUSION WAS REQUIRED FOR THE BLOOD LOSS OF MORE THAN 500 CC. PATIENT HOSPITAL STAY WAS ALSO EXTENDED FOR THREE DAYS.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 12440566 ↗MalfunctionAug 12, 2021Component or Accessory Incompatibility; Difficult to Open or Close; Component or Accessory Incompatibility; Difficult to Open or Close
ACCORDING TO THE REPORTER PRIOR TO USE, THE LOADING UNIT WAS STUCK IN CLOSED POSITION AND THERE WAS A PROBLEM LOADING THE RELOAD INTO THE ADAPTER. TO RESOLVE THE ISSUE, A NEW LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12314963 ↗
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, ClassifiedTri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
- Z-1832-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1828-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- Z-1836-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
- Z-1834-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Z-1827-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1825-2019 · May 17, 2019 · Open, ClassifiedEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Z-1826-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1833-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Z-1835-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- Z-1237-2018 · Dec 13, 2017 · TerminatedSignia" 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
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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