Tri-Staple 2.0 SIGTRSB45AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10884521717619), received between Mar 4, 2019 and Sep 28, 2026 — classified as 9 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Misfire” (43 reports).

2 other recalls cover devices cleared under the same FDA submission (K173270); 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 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Entrapment of Device; Retraction Problem

  It was reported that during a right upper lobe wedge resection, after an initial firing and loading a reload, the stapler displayed zero reloads. A reinforced reload was then used and fired; however, the knife blade failed to retract, and the reload became lockedon tissue and could not be removed. Attempts to open the reload branches with a screwdriver were unsuccessful. Another reload was used to re-staple beneath the stuck staple line, and additional right upper lobe tissue was resected. There was no patient injury. PLI50: Product was received without accompanying information.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916666 ↗
• MalfunctionSep 23, 2026Failure to Fire; Expulsion

  According to the reporter, during a partial lung resection, at the time of parenchymal resection, the lung parenchyma was clamped with a black reload, and an attempt was made to fire, but the staple did not advance. It was noted that the staple came out around the proximal side of the cartridge's jaw. The cartridge and handle were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864852 ↗
• MalfunctionAug 27, 2026Failure to Fire

  According to the reporter, intra-operatively, the reload had unfired staples.

  Patient problems: Insufficient Information

  MAUDE report 50469758 ↗
• MalfunctionMay 21, 2026

  45 BLACK REINFORCED STAPLE LOAD WOULD NOT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240148 ↗
• MalfunctionMay 4, 2026Failure to Fire; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER LOADING THE CARTRIDGE, DURING THE STAGE WHEN THE PHYSICIAN WAS APPROACHING THE T ISSUE, RE-CLAMPING WAS PERFORMED SEVERAL TIMES. AFTER THAT, WHEN FIRING, THE HANDLE COULD NOT BE SQUEEZED. A NEW HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 25075635 ↗
• MalfunctionMar 26, 2026Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT DURING A THORACOSCOPIC LOBECTOMY, UPON CHECKING THE OPENING AND CLOSING, THERE WERE NO PROBLEMS. HANDED TO THE PHYSICIAN, AND WHEN AN ATTEMPT WAS MADE TO PERFORM FIRING, A SNAPPING SOUND WAS HEARD, AND THE FIRING COULD NOT BE PERFORMED. THE HANDLE COULD NOT BE SQUEEZED. A NEW MANUAL HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706725 ↗
• MalfunctionFeb 18, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING FIRING, THE POWERED STAPLER WOULD NOT CLAMP. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE, SHELL, AND ADAPTER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24375240 ↗
• MalfunctionFeb 3, 2026Component Misassembled; Firing Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE POWERED STAPLER WAS DIFFICULT TO FIRE. A NEW RELOAD WITH THE SAME HANDLE AND ADAPTER WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE SURGERY SMOOTHLY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE CARTRIDGE APPEARED MISALIGNED AS STAPLE PUSHERS COULD BE SEEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246673 ↗
• MalfunctionJan 29, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLING WAS NOT PERFORMED WHEN FIRING WAS PERFORMED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE AND THE OPERATION WAS SUCCESSFULLY COMPLETED.

  Patient problems: Tissue Breakdown

  MAUDE report 24216461 ↗
• MalfunctionJan 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT LUNG S2 SEGMENT RESECTION, THE DEVICE COULD NOT BE SQUEEZED ON THE FIRST FIRING ATTEMPT. BOTH THE CARTRIDGE AND THE HANDLE WERE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991094 ↗
• MalfunctionOct 23, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LUNG SEGMENTECTOMY ON THE PULMONARY PARENCHYMA, THE FIRING COULD NOT BE PERFORMED AT ALL. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23364865 ↗
• MalfunctionOct 21, 2025Material Rupture; Misfire; Material Rupture; Misfire

  ACCORDING O THE REPORTER, DURING A PROCEDURE, THE FIRING WAS PERFORMED UNTIL HALFWAY THROUGH. TO RESOLVE THE ISSUE, THE SURGERY WAS CONTINUED WITH A NEW CARTRIDGE AND THE SHEET WAS CUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354024 ↗
• MalfunctionAug 19, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPIC SEGMENTECTOMY, WHEN THE PULMONARY PARENCHYMA IS RESECTED, THE FIRING STOPPED MIDWAY. THE SURGEON REPLACED IT WITH ANOTHER RELOAD BUT THE FIRING ALSO STOPPED HALFWAY THROUGH. ANOTHER DEVICE FROM OTHER COMPANY WAS USED TO RESECT AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22845682 ↗
• MalfunctionJul 29, 2025Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PULMONARY SEGMENTAL RESECTION ON THE PULMONARY PARENCHYMA, IT WAS NOT POSSIBLE TO CLOSE THE JAWS WHEN THE HANDLE WAS SQUEEZED. A NEW REINFORCED RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645332 ↗
• MalfunctionJul 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END WHILE STAPLING THE STOMACH. THIS ISSUE OCCURRED ON TWO RELOADS. DIFFERENT RELOADS WERE USED TO COMPLETE THE FIRING AND RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22583424 ↗
• MalfunctionJul 23, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC SLEEVE GASTRECTOMY, THERE WAS AN INCOMPLETE STAPLE LINE AT THE DISTAL END WHILE STAPLING THE STOMACH. THIS ISSUE OCCURRED ON TWO RELOADS. DIFFERENT RELOADS WERE USED TO COMPLETE THE FIRING AND RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22583411 ↗
• MalfunctionJul 23, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE AND THE RELOAD BOTH LOCKED ON TISSUE AND COULD NOT BE REMOVED AFTER FIRING. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES.

  Patient problems: Insufficient Information

  MAUDE report 22583097 ↗
• MalfunctionJul 18, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LUNG SEGMENTECTOMY, AT THE PULMONARY PARENCHYMA, THE GREEN BUTTON COULD NOT BE PRESSED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543780 ↗
• MalfunctionJul 9, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LEFT UPPER LOBECTOMY, THE FIRING COULD NOT BE DONE AT ALL. THE ISSUE WAS RESOLVED BY REPLACING BOTH THE CARTRIDGE AND THE HANDLE, ALLOWING THE PROCEDURE TO CONTINUE AND BE COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455168 ↗
• MalfunctionJul 3, 2025Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC (VATS) PULMONARY SEGMENTECTOMY, ON THE PULMONARY PARENCHYMA, ONLY ABOUT 2/3 OF THE CARTRIDGE COULD BE FIRED AND SEPARATED. A DIFFERENT TYPE OF RELOAD WAS USED TO CONTINUE THE RESECTION WHERE THE FIRST FIRING HAD STOPPED. IT WAS ALSO NOTED THAT THERE WAS A LEAK WHEN A LEAK TEST WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22396745 ↗
• InjuryJul 1, 2025Entrapment of Device; Human-Device Interface Problem; Entrapment of Device; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINIMALLY INVASIVE STAPLED ABDOMINAL REPAIR (MISAR) ABDOMINAL DIASTASIS PROCEDURE, AFTER FIRING, IT WAS DIFFICULT TO STRAIGHTEN THE DEVICE, AND THE JAWS OF THE RELOAD DID NOT OPEN DESPITE ALL THE ATTEMPTS TO RESET THE DEVICE. A SCREWDRIVER WAS USED, BUT IT DID NOT RESOLVE THE ISSUE. THE SURGERY WAS CONVERTED TO AN OPEN SURGERY, AND SUTURING WAS DONE TO RESOLVE THE ISSUE. THE DEVICE WAS REMOVED BY MAKING A CUT WITH SCISSORS. POST-OPERATIVELY, THE PATIENT HAD ACUTE ABDOMINAL PAIN AND TOOK MEDICATION AND PAIN RELIEF THERAPY. THE CHARGER WAS WORKING INTERMITTENTLY.

  Patient problems: Abdominal Pain; Laceration(s)

  MAUDE report 22374593 ↗
• MalfunctionMay 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS FOUND TO HAVE A PLASTIC DAMAGE AT THE CONNECTION PART OF THE ADAPTER BEFORE USE ON THE PATIENT. THE ISSUE WAS RESOLVED BY REPLACING THE PRODUCT WITH ANOTHER UNIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968153 ↗
• MalfunctionApr 29, 2025Break; Unintended System Motion; Break; Unintended System Motion

  ACCORDING TO THE REPORTER, IN A PARTIAL PULMONARY RESECTION, WHILE IN THE PULMONARY PARENCHYMA, A REINFORCED RELOAD WAS USED. AS THE KNIFE BLADE WAS BEING ADVANCED TO THE TIP, WHEN ONE ADDITIONAL PUSH WAS MADE, THE ARTICULATION PART WAS UNINTENTIONALLY GREATLY BENT. THE PART INSIDE THE ARTICULATION PART WAS DAMAGED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930001 ↗
• MalfunctionApr 21, 2025Misfire; Misfire

  IT WAS REPORTED THAT THERE WERE FIRING ISSUES WITH THE RELOAD COMPONENT OF THE POWERED STAPLER DURING A PROCEDURE. THE RELOAD COMPONENT EXPERIENCED A PARTIAL FIRE. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874160 ↗
• InjuryMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PARTIAL PULMONARY RESECTION, WHEN STAPLING THE PULMONARY PARENCHYMA A COMPONENT FROM THE DEVICE DISENGAGED AND FELL INSIDE THE PATIENT'S CAVITY. AS A RESOLUTION THE PIECE WAS RETRIEVED USING AND X-RAY AND FORCEPS.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21617296 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173270. One submission often covers many models, so check the product and lot details in each record.

• Z-1891-2024 · Apr 15, 2024 · Open, Classified
  Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anas
• Z-1419-2021 · Mar 23, 2021 · Terminated
  Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic,