MicroCutter 30 Curved Tip White Reload FG-025311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 11814900003117), received between Mar 1, 2017 and Feb 20, 2019 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2019Difficult to Remove; Physical Resistance/Sticking; Difficult to Remove; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A LOBECTOMY THROUGH A ROBOTIC VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS). THE MICROCUTTER 5/80 STAPLER AND A MICROCUTTER 30 RELOAD WERE USED ON AN INITIAL VESSEL WITHOUT ISSUE. A SECOND TRANSECTION WAS DONE ON THE SUPERIOR PULMONARY VEIN. NO BLEEDING WAS SEEN WHEN THE STAPLER JAWS WERE INITIALLY OPENED, HOWEVER, TISSUE APPEARED TO BE ADHERED TO THE LOWER JAW OF THE STAPLER. THE SURGEON THEN USED ROBOTIC GRASPERS TO REMOVE THE TISSUE FROM THE STAPLER JAW WHICH WAS SUBSEQUENTLY FOLLOWED BY BLEEDING. THE PROCEDURE WAS CONVERTED TO AN OPEN THORACOTOMY TO CONTROL THE BLEEDING. THE PATIENT LOST APPROXIMATELY 1.5 LITERS OF BLOOD, RECEIVED EMERGENCY TREATMENT AND RECEIVED A BLOOD TRANSFUSION. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS SUBSEQUENTLY DISCHARGED FROM THE ICU IN GOOD CONDITION.

  Patient problems: Blood Loss

  MAUDE report 8356560 ↗
• DeathMar 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN OPEN RIGHT HEMIHEPATECTOMY THE MICROCUTTER 5/80 STAPLER WAS USED TO DEPLOY STAPLES FROM TWO MICROCUTTER 30 RELOADS WITHOUT INCIDENT. A THIRD RELOAD WAS USED TO TRANSECT THE RIGHT PORTAL VEIN IN CLOSE PROXIMITY TO WHERE THE VESSEL BIFURCATES FROM THE PORTAL VEIN. THE VESSEL WAS TRANSECTED WITH THE STAPLER BUT IT WAS REPORTED THAT STAPLES WERE NOT PRESENT RESULTING IN AN ESTIMATED BLOOD LOSS OF 600 ML. THE BLEEDING WAS CONTROLLED BY SUTURING AND THE OPERATION WAS COMPLETED. AT THE END OF THE SURGERY, INSUFFICIENT FLOW WAS NOTED IN THE LEFT PORTAL VEIN AND A RE-ANASTOMOSIS OF THE LEFT PORTAL VEIN WAS COMPLETED, WHICH RESULTED IN SUFFICIENT FLOW IN THE LEFT PORTAL VEIN. IN THE POST-OPERATIVE PERIOD, THE PATIENT WAS REPORTED TO DEVELOP RETROGRADE THROMBUS IN THE PORTAL VEIN AND HAD SURGERY TO RELIEVE THE PORTAL VEIN NARROWING. THE PATIENT EXPERIENCED A SECOND POST-OPERATIVE INCIDENCE OF THROMBUS AND SUBSEQUENTLY EXPIRED.

  Patient problems: Blood Loss; Death; Thrombus

  MAUDE report 6370961 ↗