ENT Sinus 601-00100Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00817470006452), received between Dec 22, 2017 and Jun 1, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A NASAL SEPTUM DEVIATION CORRECTION SURGERY, SOME ANCHORS OF THE INTACT SEPTAL STAPLER 3-PACK WERE BROKEN AS THE CONTRALATERAL SIDE COULD NOT BE PENETRATED AFTER THE ANCHOR WAS DEPLOYED. THE BROKEN PIECES WERE RETRIEVED WITH SUCTION. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121243 ↗
• MalfunctionJan 20, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A NASAL SEPTUM SURGERY, THE ENTACT SEPTAL STAPLER ABSORBABLE NAIL WAS FRACTURED AFTER DEPLOYMENT AND COULD NOT BE IMPLANTED. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH SUCTION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191716 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SEPTOPLASTY PROCEDURE USING ENTACT SEPTAL STAPLER, A PATIENT EXPERIENCED A POST-OPERATIVE SYNECHIAE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Adhesion(s); Eye Injury; Inflammation; Nasal Obstruction

  MAUDE report 13804196 ↗
• MalfunctionDec 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SEPTOPLASTY, THE ENTACT SEPTAL STAPLER FELL APART AFTER THE NEEDLE BROKE AND POPPED OUT. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9519593 ↗
• MalfunctionDec 26, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A SEPTOPLASTY, THE ENTACT SEPTAL STAPLER FELL APART AFTER THE NEEDLE BROKE AND POPPED OUT. ALL FRAGMENTS WERE REMOVED USING SUCTION. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9519553 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED ABNORMAL SWELLING AFTER PROCEDURE. DESPITE SEVERAL ATTEMPTS TO GET MORE INFORMATION REGARDING PATIENT CONDITION, NO RESPONSE HAS BEEN RECEIVED FROM REPORTER.

  Patient problems: Swelling

  MAUDE report 8015153 ↗
• MalfunctionDec 22, 2017Break; Detachment Of Device Component

  IT WAS REPORTED THAT WHILE USING AN ENTACT STAPLER (601-00100) ON MONDAY AND THE TIP OF THE STAPLER BROKE. THEY SAID IT WAS JUST A PIECE OF PLASTIC THAT BROKE OFF WHEN THEY WENT TO USE .

  Patient problems: No Information

  MAUDE report 7142029 ↗