Tri-Staple 2.0 SIGTRS60AXTRecalls & reported problems
Covidien LP · Black Reinforced Intelligent Reload · Class 2 · Implant
All models of Tri-Staple 2.0 (37)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Tri-Staple 2.0 surgical stapler reload is a cartridge that places staples during surgery. Many of the 292 reports describe the stapler not firing, firing only partly, or staples not forming, and some describe a staple line that did not hold, leading to bleeding. The number of reports fell from 8 in the prior 12 months to 0 in the last 12 months. The reports include no deaths and 32 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
- 292
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 292 adverse event reports that list this exact device (DI 10884521543614), received between Mar 8, 2018 and May 28, 2025 — classified as 32 injuries, 260 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (115 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.
Reports received per month
Most reported problems
Device problems
- Failure to Fire115
- Misfire70
- Failure to Form Staple40
- Difficult to Open or Close38
- Entrapment of Device33
- Adverse Event Without Identified Device or Use Problem20
- Human-Device Interface Problem13
- Break11
Patient problems
- No Clinical Signs, Symptoms or Conditions137
- No Consequences Or Impact To Patient78
- No Known Impact Or Consequence To Patient40
- No Code Available19
- Unspecified Tissue Injury12
- Insufficient Information7
- Tissue Damage7
- Tissue Breakdown6
Recent adverse event reports
The 25 most recent of 292 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
PRODUCTS WERE RETURNED WITHOUT ACCOMPANYING INFORMATION. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE USER FIRED THE DEVICE IN TISSUE THICKER THAN INDICATED IN THE IFU.
Patient problems: Insufficient Information
MAUDE report 22102196 ↗MalfunctionApr 4, 2025Misfire; Misfire
IT WAS REPORTED THAT DURING A LOBE RESECTION PROCEDURE, THERE WERE FIRING ISSUES WITH THE POWERED STAPLER. THE DEVICE EXPERIENCED PARTIAL FIRING WHILE BEING APPLIED TO THE LOBE. TO RESOLVE THE ISSUE, THE AREA WAS RESECTED AND RE-STAPLED.
Patient problems: Insufficient Information
MAUDE report 21778072 ↗MalfunctionMar 11, 2025Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT (CABG) AND LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE, ONLY ONE STAPLE RELOAD AND ONE HANDLE WERE FIRED. THE STAPLES DID FIRE, BUT THE STAPLE LINE WAS INCOMPLETE IN SECTIONS, LEAVING HOLES. THEREFORE, THE SURGEON USED SUTURES TO OVERSEW THE ENTIRE STAPLE LINE FOR SECURITY.
Patient problems: Tissue Breakdown
MAUDE report 21577309 ↗MalfunctionFeb 28, 2025Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, AFTER OPENING THE JAWS AND CLOSING THEM AGAIN AROUND TISSUE TO CREATE THE GASTRIC SLEEVE, THE RELOAD WOULD NOT FIRE. ANOTHER RELOAD WAS USED WITH THE SAME ADAPTER AND HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21496308 ↗MalfunctionJan 10, 2025Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A BARIATRIC PROCEDURE, THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21126452 ↗InjuryNov 22, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERIAL BYPASS GRAFT PROCEDURE, AFTER THE SURGEON REMOVED THE PERFUSION PUMP CATHETER FROM THE ATRIAL APPENDAGE, THE STAPLE LINE DID NOT HOLD AND WAS INCOMPLETE CAUSING A SEVERE BLEEDING OF ABOUT 2 LITERS OF BLOOD. THE DEFECT WAS CLOSED WITH SUTURES. NO TRANSFUSION WAS REQUIRED BECAUSE THE PATIENT WAS JUST COMING OFF PUMP FROM BYPASS. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO THE ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 20762718 ↗MalfunctionNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING BYPASS SURGERY, THE SURGEON WAS REMOVING THE PERFUSION PUMP CATHETER FROM THE ATRIAL APPENDAGE WHEN THE STAPLE LINE DID NOT HOLD OR OPENED UP THE APPENDAGE OF THE HEART. THE PATIENT LOST UP TO 2 LITERS OF BLOOD. NO TRANSFUSION WAS NECESSARY BECAUSE THE PATIENT WAS COMING OFF THE PERFUSION PUMP. SUTURING WAS DONE AS A STAPLE LINE REPLACEMENT AND CONTROL THE BLEEDING. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES AS A RESULT.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 20761287 ↗InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A CORONARY ARTERIAL BYPASS GRAFT (CABG) PROCEDURE, WHEN THE SURGEONS WAS REMOVING THE PERFUSION PUMP CATHETER FROM THE ATRIAL APPENDAGE OF THE HEART WHERE TYPICALLY USE THE MANUAL HANDLE AND A RELOAD TO CLOSE THE OPENING. THE STAPLES DID NOT CLOSE AND THEREFORE THERE WAS A MAJOR BLEED. THE PATIENT LOST UP TO 2 LITERS OF BLOOD. THE SURGEON HAD TO SUTURE CLOSED THE DEFECT. NO TRANSFUSION WAS REQUIRED BECAUSE THE PATIENT WAS JUST COMING OFF THE PERFUSION PUMP. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO DEVICE ISSUE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20654873 ↗MalfunctionOct 17, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A VIDEO-ASSISTED THORACOSCOPIC PULMONARY PARENCHYMA RESECTION FOR PNEUMOTHORAX, THE DEVICE DID NOT FIRE. AFTER JAW CLOSURE, THE INITIAL SQUEEZE OF THE HANDLE COULD NOT BE PERFORMED. THE SAME ISSUE HAPPENED WITH ANOTHER RELOAD FROM THE SAME LOT. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20474309 ↗MalfunctionOct 17, 2024Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A VIDEO-ASSISTED THORACOSCOPIC PULMONARY PARENCHYMA RESECTION FOR PNEUMOTHORAX, THE DEVICE DID NOT FIRE. AFTER JAW CLOSURE, THE INITIAL SQUEEZE OF THE HANDLE COULD NOT BE PERFORMED. THE SAME ISSUE HAPPENED WITH ANOTHER RELOAD FROM THE SAME LOT. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20473856 ↗MalfunctionJul 2, 2024Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD A STAPLE FORMATION ISSUE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 19660895 ↗MalfunctionDec 14, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC TAIL RESECTION, WHEN RESECTING THE PANCREAS, THE JAWS WERE SET-UP AND CLOSED ON THE PANCREAS. AFTER THAT, FIRING WAS ADVANCED, BUT UPON ADVANCING BY ONE CM, THE FIRING STOPPED. EVEN AFTER PRESSING ANY BUTTON, NOTHING STARTED TO RESPOND. THE SCREEN STATUS OF THE HANDLE REMAINED STUCK AT ZONE TWO, AND THERE WAS NO CHANGE. BOTH SIDES OF THE GREEN BUTTON WERE PRESSED FOR 10 SECONDS, AND REBOOT AND A RELEASE FROM THE TISSUE WERE PERFORMED. THE TISSUE HAS NOT BEEN STAPLED, AND THE RELEASE COULD BE PERFORMED WITHOUT ANY PROBLEM. AFTER THAT, A NEW POWERED HANDLE AND CARTRIDGE WERE BROUGHT IN AND USED, AND THE SURGERY WAS COMPLETED. AFTER THE PROCEDURE, THE DEFECTIVE POWERED STAPLER AND ADAPTER WERE TESTED WITH NON-STERILE, AND IT COULD BE USED WITHOUT PROBLEM. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18327407 ↗MalfunctionOct 24, 2023Entrapment of Device; Entrapment of Device
ACCORDING TO THE REPORTER, DURING AN OPEN LEFT ATRIAL APPENDAGE PROCEDURE, THE DEVICE JAWS LOCKED ON TISSUE. THE SURGEON OVER-SEWED THE LEFT ATRIAL APPENDAGE AND HAD TO CUT THE TISSUE AWAY TO RESOLVE THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 17995111 ↗MalfunctionSep 18, 2023Entrapment of Device; Misfire; Entrapment of Device; Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC BODY AND TAIL RESECTION, AT THE TIME OF PANCREATECTOMY, THE FIRING WAS ADVANCED 1CM EVERY MINUTE. HOWEVER, WHEN IT REACHED 4CM, THE KNIFE SUDDENLY RETURNED AND THE FIRING WAS INCOMPLETE. IT WAS NOTED THE PANCREAS WAS NEITHER PARTICULARLY THICK NOR HARD, AND WAS OPERATED AS USUAL. ADDITIONAL RESECTION WAS PERFORMED ON BOTH SIDES OF THE RELOAD USING A NEW RELOAD TO REMOVED THE DEVICE. THE SAME POWERED DEVICE WAS USED WITH THE NEW RELOAD. THIS LED TO LESS THAN 1 INCH EXTENDED INCISION.
Patient problems: Tissue Breakdown; Unspecified Tissue Injury
MAUDE report 17763271 ↗MalfunctionAug 21, 2023Entrapment of Device; Entrapment of Device
ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATICODUODENECTOMY, WHILE RESECTIONING PANCREATIC PARENCHYMA, THE JAWS DID NOT OPEN AFTER THE COMPLETION OF FIRING. AFTER A WHILE, THE JAWS OPENED AND THERE WAS NOTHING IN PARTICULAR DONE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17591261 ↗MalfunctionJul 10, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IN THE FIRING ON THE STOMACH NEAR THE PYLORUS, THE TWO RELOADS FIRED ONLY HALFWAY. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17292454 ↗MalfunctionJul 10, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IN THE FIRING ON THE STOMACH NEAR THE PYLORUS, THE TWO RELOADS FIRED ONLY HALFWAY. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17292306 ↗MalfunctionJul 10, 2023Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING MIDDLE PANCREATECTOMY, AFTER CONFIRMING THAT ALL INDICATORS WERE GREEN, THE JAWS WERE SET TO THE P ANCREAS AND CLOSURE WAS PERFORMED. WHEN THE CLOSING OF THE JAWS WAS HALFWAY COMPLETED, IT DID NOT MOVE; EVEN WHEN THE BUTTON WAS PRESSED TO FURTHER CLOSED IT. WHEN CHECKED, ALL INDICATORS WERE STILL GREEN BUT AN ERROR SOUND CONTINUED TO INTERMITTENTLY SOUND. THE JAWS WERE OPENED AND REMOVED AND A NEW SHELL, RELOAD, AND HANDLE WERE USED WITH THE SAME ADAPTER TO RESOLVE THE ISSUE. THE DEFECTIVE DEVICES WERE REMOVED FROM THE STERILE FIELD AND CHECKED. THE HANDLE'S DISPLAY CONTINUED TO SHOW THAT ALL INDICATORS WERE GREEN EVEN THOUGH THE ADAPTER, RELOAD, AND SHELL WERE REMOVED AND AN INTERMITTENT ERROR SOUND WAS HEARD. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17288518 ↗MalfunctionJul 6, 2023Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE AT SECOND FIRING OF THE STAPLER OVER STOMACH, DEVICE CYCLED PROPERLY, THERE WERE BLINKING GREEN LIGHTS ON ALL THREE LANES INDICATING READY TO FIRE, ADAPTER READ RELOAD, BUT WHEN THE DOCTOR PRESSED DOWN ON STAPLER TO FIRE, THE KNIFE BLADE WOULD NOT ADVANCE, STAPLER WOULD NOT FIRE. AFTER THE FIRST ATTEMPT TO FIRE THE RELOAD, SCRUB TECHNICIAN REATTACHED RELOAD, BUT THE LANE WAS WHITE ON RELOAD INDICATOR ON STAPLER WINDOW, SAID IT HAD BEEN USED. THE RELOAD WAS REPLACED, WHILE SAME HANDLE AND ADAPTER WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17274379 ↗MalfunctionJun 28, 2023Misfire; Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LAPAROTOMY PANCREATIC TAIL RESECTION, THE RESECTION WAS PERFORMED AS CLAMPED WITH ONE MINUTE WAIT TIME AND IN SLOW MODE FIRE WITH ONE CM LOOP. WHEN IT ADVANCED BY ABOUT TWO CM, THE FIRING STOPPED AND THE LOWER BUTTON OF THE CENTER CONTROL DID NOT RESPOND. THE RELEASE WAS PERFORMED AS IS, AND ANOTHER CARTRIDGE OF THE SAME PRODUCT NUMBER WAS USED WITH THE SAME HANDLE, SHELL AND ADAPTER, AND THE RESECTION WAS PERFORMED WITHOUT ANY PROBLEM. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17217593 ↗MalfunctionJun 20, 2023Entrapment of Device; Misfire; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Misfire; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC TAIL RESECTION (LAPAROTOMY), WHILE FIRING WITH REINFORCED 60 BLACK RELOAD WITH POWERED STAPLER IN PANCREATIC TAIL RESECTION, THE FIRING ADVANCED FOR ABOUT 30 MM, BUT FIRING STOPPED, ADVANCING STOPPED AND RELEASE COULD ALSO NOT BE DONE. THE DISPLAY WAS OFF. DEVICE WAS LOCKED INTO THE TISSUE, THAT WAS ABLE TO DETACH BY POWER APPROACH. THE SURGERY TIME WAS EXTENDED BY 30 MINUTES OR MORE AND INCISION RANGE EXPANDED LESS THAN 1 INCH (2.54 CM). A NEW SET OF POWERED STAPLER WAS USED TO RESECT THE CENTRAL SIDE AND COMPLETE THE CASE. THE ADAPTER WAS USED WITH ANOTHER HANDLE AND THE POWER SHELL AND WERE ABLE TO BE USED WITH NO PROBLEM.
Patient problems: Unspecified Tissue Injury
MAUDE report 17165191 ↗MalfunctionMay 25, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC TAIL RESECTION, DURING RESECTING THE PANCREAS AFTER COMPRESSIONS, WHILE USING A POWERED STAPLER, THE PANCREAS WAS CLAMPED, THE GREEN BUTTON DID NOT LIGHT UP, AND THE FIRING COULD NOT BE PERFORMED. THE PANCREAS HAD BEEN PRE-COMPRESSED AND WAS QUITE THIN, AND THERE WAS NO INDICATION THAT IT WAS OUT OF INDICATED APPLICABLE RANGE. AFTER THAT, ALL COMPONENTS, INCLUDING THE CARTRIDGE WERE REMOVED, BUT THE LCD SCREEN OF THE HANDLE REMAINED IN FIRING PREPARATION COMPLETE STATE, AND THE HANDLE WAS IN A FROZEN STATE. THE SURGEON USED A MANUAL STAPLER WITH A NEW CARTRIDGE TO RESOLVE THE ISSUE. AFTER THAT, THE HANDLE WAS THEN RESTARTED WITH A POWER RESET, AND THE DEVICE STARTED UP NORMALLY. THE SURGICAL PROCEDURE WAS EXTENDED BY MORE THAN 30 MINUTES WITH NO ADVERSE EVENT TO THE PATIENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17002985 ↗MalfunctionApr 24, 2023Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY PROCEDURE, WHILE RESECTIONING THE PULMONARY PARENCHYMA BY RIGHT UPPER LOBECTOMY, A CRACKING SOUND WAS HEARD WHEN THE FIRING ADVANCED ABOUT 2CM. THE FIRING WAS ABLE TO BE COMPLETED, BUT THE JAWS DID NOT OPEN WHEN THE SURGEON ATTEMPTED RELEASING THE DEVICE BY PULLING THE BLACK RETURN KNOB. IT WAS NOTED THAT THE INTERNAL GEAR AND THE BLACK RETURN KNOB WERE DAMAGED. AN ADDITIONAL RESECTION WAS PERFORMED USING ANOTHER RELOAD AND HANDLE. THIS LED TO TISSUE DAMAGE AND 30 MINUTES OR MORE EXTENDED SURGICAL TIME.
Patient problems: Unspecified Tissue Injury
MAUDE report 16797938 ↗MalfunctionApr 1, 2023Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC TAIL RESECTION, WHEN THE HANDLE WITH 60MM RELOAD APPROACHED TO RESECT THE TAIL OF THE PANCREAS, AFTER SEVERAL TIMES, THE HANDLE STARTED TO RUN IDLE AND THE JAWS COULD NOT BE CLOSED. THE NEW HANDLE WAS TAKEN OUT, WITH A NEW REINFORCED BLACK RELOAD; THE JAWS WERE UNABLE TO BE CLOSED AND THE FIRING COULD NOT BE PERFORMED. THE GREEN BUTTON WAS UNABLE TO BE PRESSED UNABLE TO SQUEEZE THE HANDLE. A LINEAR CUTTER FROM A DIFFERENT COMPANY WAS USED IN ORDER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16660710 ↗MalfunctionMar 16, 2023Entrapment of Device; Misfire; Failure to Form Staple; Entrapment of Device; Misfire; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATECTOMY, WHEN THE PANCREATIC PARENCHYMA WAS RESECTED, THE FIRING COULD NOT ADVANCE HALFWAY THROUGH FOR THE FIRST FIRING DURING PANCREATIC RESECTION USING THE DEVICE. A FEW STAPLES WERE STICKING OUT AT 1CM FROM PROXIMAL SIDE OF THE RELOAD USED DURING THE FIRST FIRING. IT SEEMS THAT CLAMP COVER (SLED) ADVANCED ABOUT 1CM BUT THE FIRING TO THE TISSUE WAS UNABLE TO BE PERFORMED. THERE WAS AN EXCESSIVE FORCE POINTS TO "1" AND THE ARTICULATION WAS ALSO ONLY SLIGHTLY ARTICULATED. NEITHER MOVING FORWARD NOR BACKWARD WERE POSSIBLE WITH THE CENTER CONTROL. BOTH GREEN BUTTONS WERE LONG PRESSED, AND WAS RESTARTED TO OPEN THE JAWS, THEN IT WAS RELEASED FROM THE TISSUE. AFTERWARDS, A NEW RELOAD WAS USED AND RESECTION WAS POSSIBLE WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16553918 ↗
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-1833-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Z-1825-2019 · May 17, 2019 · Open, ClassifiedEGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
- Z-1829-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
- Z-1834-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
- Z-1832-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
- Z-1826-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
- Z-1828-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
- Z-1836-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
- Z-1827-2019 · May 17, 2019 · Open, ClassifiedEGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
- Z-1835-2019 · May 17, 2019 · Open, ClassifiedSIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
- Z-1831-2019 · May 17, 2019 · Open, ClassifiedEGIA45 CT AR MD THK REL, EGIA45CTAMT
- Z-1830-2019 · May 17, 2019 · Open, ClassifiedEGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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