HANDPIECE FOR ATEC BIOPSY SYSTEM

Description of Event or Problem

RECEIVED NOTIFICATION FROM A CUSTOMER OF THE RECEIPT OF A HANDPIECE FOR WHICH THE PRIMARY PACKAGING POUCH (STERILE BARRIER) WAS NOT SEALED PROPERLY. THE STERILIZATION WRAP WHICH ENCLOSES THE PRODUCT INSIDE THE POUCH WAS STILL INTACT. THE UNSEALED PACKAGING WAS FOUND DURING THE CUSTOMER'S INITIAL RECEIPT, AND NO PRODUCT WAS USED CLINICALLY.

Additional Manufacturer Narrative

CONCLUSION: PACKAGING INTEGRITY- STERILE BARRIER COMPROMISED. ON MARCH 17, 2006, THE QUALITY & REGULATORY DEPARTMENT AS SUROS SURGICAL SYSTEMS RECEIVED A COMPLAINT FROM ADVANCED IMAGING IN PORT CHARLOTTE, FLORIDA, REGARDING A BREACHED STERILE BOUNDARY DUE TO IMPROPER SEALING AT THE MANUFACTURER SITE OF THE PACKAGING FOR THE ATEC 0912-20 HANDPIECE. AFTER REVIEW OF THE SITUATION AND REPORTING REQUIREMENTS, THE DECISION WAS MADE THAT THIS DID NOT CONSTITUTE A REPORTABLE EVENT. AT THAT TIME, THE CREATION OF COMPLAINT WAS COMPLETED BY THE QUALITY AND REGULATORY GROUP.