MalfunctionFXY
T7PLUS HOOD W ANTI-REFLECTIVE LENS
Received Jan 31, 2025 · Event occurred Sep 11, 2024
Report 3015967359-2025-00375 · MDR key 21282717
Device
Generic name
Gown, Surgical
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0416801200
Lot number
P000578824
Product problems
- Material Frayed
- Material Frayed
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EVENT IN THIS RECORD WAS PREVIOUSLY REPORTED UNDER MFR REPORT # 3015967359-2024-02211 BUT SHOULD BE INCLUDED UNDER THIS REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DURING A PREPARATION FOR A THA, AT THE USER FACILITY, THE SURGEON NOTICED A LOOSE THREAD ON THE HOOD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.