T7PLUS ZIPPER TOGA W ANTI-REFLECTIVE LENS XL
Received Jun 5, 2024 · Event occurred May 13, 2024
Report 3015967359-2024-01120 · MDR key 19473404
Device
Generic name
Gown, Surgical
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0416831200
Lot number
UNKNOWN
Product problems
- Unraveled Material
- Unraveled Material
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE CLOSING DURING A TOTAL KNEE PROCEDURE AT THE USER FACILITY FIBERS FROM DEVICE WAS FOUND ON THE JOINT AND HAD TO RE IRRIGATE THE KNEE TO FLUSH THE FIBERS OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE CLOSING DURING A TOTAL KNEE PROCEDURE AT THE USER FACILITY FIBERS FROM DEVICE WAS FOUND ON THE JOINT AND HAD TO RE IRRIGATE THE KNEE TO FLUSH THE FIBERS OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
FOLLOW-UP REPORT SUBMITTED TO DOCUMENT DEVICE EVALUATION RESULTS.