MalfunctionGAS
NON-ABSORBABLE SURGICAL SUTURES
Received Dec 22, 2010
Report 2523835-2010-00152 · MDR key 1940122
Device
Generic name
Non-absorbable Suture
Manufacturer
Alcon Precision Device - Sinking SpringModel number
8065710401Catalog number
8065710401
Lot number
806496M
Product problems
- Break
Patient
NI
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
A HOSPITAL PHARMACIST REPORTED ON BEHALF OF A SURGEON THAT THE SUTURES BROKE TOO EASILY. THIS CAUSED A CASE TO BE EXTENDED FOR AN ADD'L 30 MINUTES. IT WAS REPORTED THAT THERE WAS NO PT HARM.