173016 @ENDO STITCH 10 MM SUTURING DEVIC
Received Feb 1, 2023 · Event occurred Dec 20, 2022
Report 3032391-2023-00001 · MDR key 16280476
Device
Generic name
173016 @endo Stitch 10 Mm Suturing Devic
Manufacturer
Medline RenewalCatalog number
173016R
Lot number
485663
Product problems
- Material Integrity Problem
- Material Integrity Problem
Patient
Unknown
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON (B)(6) 2022 THE ENDO STITCH NEEDLE BROKE INSIDE THE VAGINAL CUFF AND HAD TO BE RETRIEVED FROM THE PATIENT. PER THE FACILITY AN ADDITIONAL 20 MINUTES WAS ADDED TO THE CASE REQUIRING ADDITIONAL ANESTHESIA. NO ADDITIONAL INFORMATION WAS PROVIDED. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE FACILITY ON (B)(6) 2022 THE ENDO STITCH NEEDLE BROKE INSIDE THE VAGINAL CUFF AND HAD TO BE RETRIEVED FROM THE PATIENT.
Additional Manufacturer Narrative
THE SAMPLE WAS RETURNED FOR EVALUATION, HOWEVER, THE REPORTED ISSUE WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.