GHIATAS LOCALIZATION WIRE

Additional Manufacturer Narrative

THE LOT NUMBER WAS PROVIDED FOR THE ONE MALFUNCTION; THEREFORE, A LOT HISTORY REVIEW IS CURRENTLY BEING PERFORMED. THE DEVICE WAS RETURNED FOR EVALUATION AND THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME.

Description of Event or Problem

THIS REPORT SUMMARIZES THE ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 479201 BREAST LOCALIZATION WIRE ALLEGEDLY EXPERIENCED SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE SIGNAL ARTIFACT, ONE INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT INFORMATION WAS NOT PROVIDED.

Additional Manufacturer Narrative

H10: THE LOT NUMBER WAS PROVIDED FOR THE MALFUNCTION, AND A LOT HISTORY REVIEW WAS PERFORMED. THE SAMPLE WAS RETURNED FOR EVALUATION AND IMAGES WERE PROVIDED FOR REVIEW. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE WAS LABELED FOR SINGLE USE. H10: G4 H11: B5 H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

Description of Event or Problem

THIS REPORT SUMMARIZES THE ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 479201 BREAST LOCALIZATION WIRE ALLEGEDLY EXPERIENCED SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

Description of Event or Problem

THIS REPORT SUMMARIZES THE ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 479201 BREAST LOCALIZATION WIRE ALLEGEDLY EXPERIENCED SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

Additional Manufacturer Narrative

H10: THE LOT NUMBER WAS PROVIDED FOR THE MALFUNCTION, AND A LOT HISTORY REVIEW WAS PERFORMED. THE SAMPLE WAS RETURNED FOR EVALUATION AND IMAGES WERE PROVIDED FOR REVIEW. BASED ON THE IMAGE REVIEW, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED IMAGING ARTIFACT. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE DEVICE WAS LABELED FOR SINGLE USE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.