MalfunctionGDF
45 LEFT DISPOSABLE SUTURE SLIDER WITH NITINOL LOO
Received Mar 27, 2008 · Event occurred Feb 25, 2008
Report 2936485-2008-00017 · MDR key 1024223
Device
Generic name
Suture Slider
Manufacturer
Stryker Endoscopy San JoseCatalog number
3910000104
Lot number
05256AG2
Product problems
- Device, or device fragments remain in patient
- Tip breakage
- Device, removal of (non-implant)
Patient
UNK
- Nonresorbable materials, unretrieved in body
- Foreign body, removal of
- Surgical procedure, additional
Narrative
Description of Event or Problem
DURING A SURGERY PROCEDURE, THE SURGEON NOTED THAT THE TIP OF THE SUTURE SLIDER BROKE OFF. THE SURGEON TRIED TO REMOVE ALL BROKEN PIECES. AS PARTS OF THE TIP STILL REMAIN IN THE PATIENT, A REVISION SURGERY BECAME NECESSARY.
Additional Manufacturer Narrative
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE COMPLAINT INVESTIGATION.