MicroCutter 30 White Reload FG-025310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 11814900003100), received between Apr 5, 2017 and Jun 20, 2017 — classified as 1 injury, 1 malfunction.

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

• InjuryJun 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PROCEDURE WAS A ROBOTIC LEFT LOWER LOBECTOMY. THE MICROCUTTER 5/80 STAPLER WAS LOADED WITH A MICROCUTTER 30 WHITE RELOAD AND WAS POSITIONED FOR TRANSECTION OF THE INFERIOR (LOWER LOBE) PULMONARY VEIN. A BRAIDED SILK SUTURE WAS USED TO FACILITATE PLACEMENT OF TISSUE INTO THE DEVICE AND WAS THEN REMOVED PRIOR TO FIRING THE STAPLER. UPON INITIAL INSPECTION, THE STAPLE LINE WAS HEMOSTATIC ON BOTH THE PATIENT AND THE SPECIMEN SIDES OF THE TRANSECTION. THE SURGEON MANIPULATED THE LOBE POST TRANSECTION OF THE INFERIOR PULMONARY VEIN (IPV) AND OOZING WAS NOTED ON THE SPECIMEN SIDE OF THE STAPLE LINE. OOZING WAS CONTROLLED BY USING A COVIDIEN STAPLER. THE PATIENT SIDE OF THE TRANSECTION REMAINED HEMOSTATIC. THE SURGEON CONTINUED WITH THE SURGICAL PROCEDURE INCLUDING TRANSECTING THE SUPERIOR SEGMENTAL ARTERY USING A MICROCUTTER 5/80 STAPLER. THE LUNG SPECIMEN WAS REMOVED FROM THE PATIENT. APPROXIMATELY 45 TO 60 MINUTES AFTER TRANSECTING THE IPV AND AFTER REMOVING THE SPECIMEN, THE LOWER LOBE HILAR REGION BEGAN TO BLEED. THE PATIENT WAS CONVERTED TO AN OPEN THORACOTOMY AND THE SURGEON COMMUNICATED THE AREA OF CONCERN WAS THE INFERIOR PULMONARY VEIN. HE WASN'T ABLE TO VISUALIZE THE STAPLE

  Patient problems: Blood Loss

  MAUDE report 6655512 ↗
• MalfunctionApr 5, 2017Misfire; Misfire

  THE SURGEON WAS PERFORMING AN OPEN THORACOTOMY. THE MICROCUTTER 5/80 STAPLER AND A MICROCUTTER 30 CURVED TIP BLUE RELOAD WERE USED TO DIVIDE A BASAL BRANCH OF THE PULMONARY ARTERY WITH ACCEPTABLE RESULTS. THE STAPLER AND THE MICROCUTTER 30 WHITE RELOAD WERE THEN USED TO DIVIDE A SMALL SEGMENTAL PULMONARY ARTERY BRANCH WITH RESULTANT BLEEDING NOTED AT THE PATIENT SIDE OF THE STAPLE LINE. THERE DID NOT APPEAR TO BE ANY BLEEDING FROM THE SPECIMEN SIDE OF THE SEGMENTAL PULMONARY ARTERY BRANCH DIVISION. THE SURGEON REPORTED THAT THERE DID NOT SEEM TO BE ANY STAPLES PRESENT IN THE VESSEL. THE SURGEON THEN PLACED SUTURES ON BOTH SIDES OF THE TRANSECTED SEGMENTAL PULMONARY ARTERY BRANCH. A DIFFERENT STAPLER AND DIFFERENT RELOADS WERE USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTED COMPLICATIONS.

  Patient problems: Blood Loss

  MAUDE report 6462709 ↗