ENT Sinus 601-00100SRecalls & reported problems
Smith & Nephew, Inc. · ENTACT SEPTAL STAPLER 1-PACK · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817470006469), received between Jul 31, 2018 and Jul 31, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Fire” (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
Device problems
- Failure to Fire1
- Failure to Form Staple1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2018Failure to Form Staple; Failure to Fire
IT WAS REPORTED THAT THE FIRST STAPLER FAILED TO DISPENSE ANY SUTURES, BACK UP DEVICE WAS USED AND SUTURES DID NOT STAY IN THE SEPTUM. A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURIES WERE REPORTED. LOCAL ANESTHESIA WAS USED. A BACKUP WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7736259 ↗
Other Septal Stapler/Absorbable staples devices
- ENT Sinus 601-00100Smith & Nephew, Inc. · Septal Stapler/Absorbable staples7 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.