ULTRACOR BREAST TISSUE MARKER

Description of Event or Problem

THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL: UCTC17GSS BIOPSY INSTRUMENT APPEARED TO BE LARGER THAN OTHER DEVICES OF THE SAME TYPE UNDER MRI. THIS MALFUNCTION WAS REPORTED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

Additional Manufacturer Narrative

H10: THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER MRI IMAGES WERE RECEIVED; REVIEW OF THE IMAGES BY A MEDICAL PROFESSIONAL INDICATED THAT THE AMOUNT OF BLOOMING ARTIFACT GIVEN BY THE DEVICE IS NORMAL. THE DEVICE IS LABELED FOR SINGLE USE. H10: G4: PMA/510K. H11: B5: EVENT, H6 (RESULTS, CONCLUSION). 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.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION, HOWEVER MRI IMAGES WERE RECEIVED, THEREFORE THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL UCTC17GSS BIOPSY INSTRUMENT APPEARED TO BE LARGER THAN OTHER DEVICES OF THE SAME TYPE UNDER MRI. THIS EVENT WAS REPORTED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED INJURY. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.