InjuryGAS
SURGIPRO
Received May 21, 2009
Report MW5011211 · MDR key 1393293
Device
Generic name
Surgipro
Product problems
- Disassembly
- Inadequacy of Device Shape and/or Size
- Out-Of-Box Failure
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
COVIDIEN, MAKER OF SYNETURE SURGICAL SUTURES MANUFACTURES SUTURES OF VARIOUS LENGTHS. THE LENGTH AS CLAIMED ON THE PACKAGE DOES NOT MEASURE TO BE THE SAME. THE SURGEON FIRST NOTICED THIS VISUALLY. UPON MEASURING THE SUTURE LENGTH IT WAS FOUND TO BE OFF BY SEVERAL INCHES. THIS OCCURRED IN MANY OPEN PACKAGES AND IS STILL OCCURRING. THE COMPANY HAS BEEN NOTIFIED ON TWO OCCASIONS.