INVIVO

Additional Manufacturer Narrative

PHILIPS CONDUCTED A CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) OF WHICH THE FOLLOWING IS THE SUMMARY: THE INVESTIGATION HAS SHOWED THAT THERE WAS NO PRODUCT MALFUNCTION. THE INVESTIGATION SHOWED THAT THE CUSTOMER FAILED TO COMPLY WITH THE INSTRUCTIONS FOR USE (IFU) IN THE FOLLOWING WAY: AS PER INSTRUCTIONS THE USAGE IS AS FOLLOWS: IFU 4535-303-07841, PAGE NO.4 CLEARLY STATES THAT ¿BEFORE THE INTERVENTION IS PERFORMED, A CONFIRMATION SCAN SHOULD BE ACQUIRED WITH THE SLEEVE (AND POSSIBLY STYLET) INSERTED TO ENSURE THAT THE NEEDLE IS POSITIONED AS DESIRED. INCORPORATE THE EFFECTS OF NEEDLE THROW INTO THE RISK EVALUATION.¿ IT WAS FOUND TO BE CONDUCTED INSTEAD : THE OPERATOR / PHYSICIAN HAD PERFORMED THE VACUUM ASSISTED BIOPSY WITHOUT CONSIDERING THE MANUFACTURER¿S IFU, WHICH RESULTED IN ¿LESS COMPRESSION IN MEDIAL PLATES CAUSED SPATIAL MOVEMENT OF THE TARGET LESION CONSEQUENTLY MISSING THE TARGET LESION DUE TO WHICH PHYSICIAN HAD TO TARGET 12 BIOPSIES LEAD TO 5CM CUT ON THE MEDIAL SIDE OF THE BREAST. ¿ THE PATIENT REQUIRED A CORRECTIVE PROCEDURE AND HAS SINCE RECOVERED.

Description of Event or Problem

IT WAS REPORTED THAT DUE TO THE INSUFFICIENT MEDIAL COMPRESSION PLATE IN THE MRI, A LARGE DEFECT IN THE BREAST OCCURRED DURING A VACUUM BIOPSY. THERE IS NO INDICATION OF A COIL OR SYSTEM MALFUNCTION.

Additional Manufacturer Narrative

PHILIPS HAS STARTED AN INVESTIGATION, A FOLLOW UP WILL BE SUBMITTED ONCE COMPLETED.