Dextera MicroCutter 5/80 Stapler FG-025302Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 11814900003025), received between Jan 5, 2017 and May 19, 2017 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Positioning Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 19, 2017Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  THE PATIENT WAS UNDERGOING A RIGHT LUNG MIDDLE LOBECTOMY BY ROBOTIC VIDEO-ASSISTED THORACIC SURGERY. THE MICROCUTTER 5/80 STAPLER WAS ADVANCED THROUGH THE ACCESSORY PORT TROCAR TO A BRANCH OF THE SUPERIOR PULMONARY VEIN FOLLOWING DISSECTION OF TISSUE AROUND THE TARGET VEIN. WHILE POSITIONING THE STAPLER AT THE SELECTED LOCATION FOR TRANSECTION OF THE VEIN AND PRIOR TO FIRING THE STAPLER, BLEEDING OCCURS WHICH APPEARS TO HAVE ORIGINATED FROM BEHIND THE TARGET VEIN. IT APPEARS THAT A SMALL BRANCH VESSEL, LOCATED BEHIND THE TARGET VEIN, MAY HAVE AVULSED WHEN THE MICROCUTTER 5/80 STAPLER WAS BEING POSITIONED, RESULTING IN BLEEDING. THE STAPLER IS SUBSEQUENTLY FIRED RESULTING IN A SUCCESSFUL STAPLE LINE. THE SURGEON THEN USES PRESSURE TO CONTROL THE BLEEDING. ADDITIONAL BLEEDING IS NOTED AT THE DISTAL END OF THE TRANSECTED VESSEL. THE SURGEON CONTROLS THE BLEEDING THROUGH THE USE OF DIRECT PRESSURE, CAUTERY, TOPICAL HEMOSTATIC AGENTS AND CLIPS. THE SURGERY WAS COMPLETED AND IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY FURTHER COMPLICATIONS AS A RESULT OF THE BLEEDING AND IS DOING WELL.

  Patient problems: Blood Loss

  MAUDE report 6580091 ↗
• DeathJan 5, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED AN ADVERSE EVENT THAT OCCURRED DURING A RIGHT UPPER LOBECTOMY AND LOWER LOBE WEDGE RESECTION VIA A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS). WHILE POSITIONING THE STAPLER BEHIND THE RIGHT UPPER LOBE SEGMENTAL PULMONARY ARTERY BRANCH, THE STAPLER WAS PUSHED SOMEWHAT FORCEFULLY AND THE VESSEL TORE DISTAL TO THE SITE TARGETED FOR TRANSECTION OF THE VESSEL. THE STAPLES WERE THEN DEPLOYED IN THE PROXIMAL PORTION OF THE VESSEL, RESULTING IN A SUCCESSFUL STAPLE LINE. THE SURGICAL PROCEDURE WAS CONVERTED TO AN OPEN THORACOTOMY DUE TO THE DISTAL TEAR AND SUBSEQUENT BLEEDING. FOLLOWING THE CONVERSION, THE SURGEON OBSERVED THAT THE STAPLES REMAINED INTACT AND THERE WAS NO ISSUE WITH THE DISTAL STAPLE LINE, HOWEVER THE TEAR WAS NOTED DISTAL TO THE STAPLE LINE. IN A SUBSEQUENT COMMUNICATION ON (B)(6) 2017, THE SURGEON REPORTED THAT THE PATIENT HAD EXPIRED. IT WAS REPORTED BY THE HOSPITAL PERSONNEL THAT THE PATIENT WAS EXPIRED FROM SEPSIS ON (B)(6) 2016.

  Patient problems: Renal Failure; Respiratory Failure; Sepsis; Unspecified Infection

  MAUDE report 6227739 ↗