MalfunctionGAS
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
Received Jun 7, 2010
Report 2210968-2010-00606 · MDR key 1723768
Device
Generic name
Suture, Nonabsorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
EH7579H
Lot number
CA2JBWM0
Product problems
- Break
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN EAR, NOSE AND THROAT SEPTUM DEFECT PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE NEEDLE BROKE DURING USE ON THE PATIENT. THERE WAS NO ADVERSE PATIENT CONSEQUENCE.
Additional Manufacturer Narrative
(B)(4): RESULTS: REPRESENTATIVE SAMPLES OF THE PRODUCT WERE RETURNED FOR EVALUATION. THE NEEDLES WERE INSPECTED AND TESTED FOR STRENGTH. THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.