ENTACT SEPTAL STAPLER 3-PACK
Received Dec 26, 2019 · Event occurred Nov 29, 2019
Report 3006524618-2019-00617 · MDR key 9519553
Device
Generic name
Septal Stapler/absorbable Staples
Manufacturer
Arthrocare Corp.Model number
601-00100Catalog number
601-00100
Lot number
01908004
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
H10: THE DEVICE REPORTED, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. A PICTURE OF THE DEVICE HAS BEEN SENT. PER THE CUSTOMER PHOTOS, THERE IS NO VISUAL IDENTIFICATION THAT THE ADHESIVE APPLICATION INTO THIS DEVICE WAS PERFORMED. THE RELATIONSHIP BETWEEN THE PRODUCT AND REPORTED WAS ESTABLISHED. A REVIEW OF MANUFACTURING RECORDS FOR THE REPORTED LOT NUMBER 01908004 FOUND NO NON-CONFORMANCES OR ANOMALIES DURING MANUFACTURING PROCESS RELATED TO THE REPORTED EVENT. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE A MANUFACTURING PROCESS ERROR. MANUFACTURING RECORDS REVIEW WAS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT, DURING A SEPTOPLASTY, THE ENTACT SEPTAL STAPLER FELL APART AFTER THE NEEDLE BROKE AND POPPED OUT. ALL FRAGMENTS WERE REMOVED USING SUCTION. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.