THIS IS A MEDICAL DEVICE REPORT OF PROSTATE SEEDING NEEDLES SEEMING TO BE LESS SHARP THAN USUALLY EXPECTED. THIS MEDICAL DEVICE REPORT WAS RECEIVED FROM THE MEDICAL PHYSICIST AND ADDITIONAL INFORMATION WAS PROVIDED BY A PHYSICIAN ON (B)(6) 2011 (THE SAME DAY AS THE INITIAL REPORT). THE REPORTER CONFIRMED THAT THREE UROLOGISTS HAD PROVIDED FEEDBACK STATING THAT DURING A BRACHYTHERAPY PROCEDURE, THE NEEDLES APPEARED TO BE LESS SHARP THAN USUAL AND WERE NOT SHARP ENOUGH TO PENETRATE THE PERINEAL WALL WELL. THE REPORTER ALSO STATED THAT THE NEEDLE DEFLECTION/TRAJECTORY SEEMS MORE VARIABLE (DUE TO DEEPLY INDENTED SKIN BEFORE THE NEEDLE PENETRATES WHICH ALTERS THE ORIENTATION OF THE NEEDLE SLIGHTLY). THE REPORTER ALSO STATED THAT ONE UROLOGIST HAD THOUGHT THAT THE TROCAR TIP WAS SHARP BUT WAS HANGING UP AT THE FRONT EDGE OF THE OUTER NEEDLE.
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COMPANY COMMENT: A GROUP OF HCP'S COMPLAINED THAT THEY FELT THE NEEDLES WERE NOT SHARP ENOUGH, RESULTING IN GREATER DIFFICULT PENETRATING THE PERINEAL SKIN, AND "NEEDLE DEFLECTION/TRAJECTORY SEEMS MORE VARIABLE". WHILE THERE IS NO MENTION OF ANY HARM OCCURRING TO ANY PATIENT DUE TO THESE EVENTS, THE POTENTIAL FOR HARM DOES EXIST, AND THIS IS THEREFORE A REPORTABLE EVENT. IF THE NEEDLE TRAJECTORY OBTAINED BY THE PHYSICIAN IS DIFFERENT THAN THE ONE INTENDED BY THE TREATING PHYSICIAN BECAUSE OF PROBLEMS WITH THE DEVICE, SEEDS COULD INADVERTENTLY BE PLACED IN LOCATIONS OTHER THAN THAT INTENDED. THIS RAISES A NUMBER OF POTENTIAL HARM ISSUES INCLUDING INADEQUATE TREATMENT OF THE PATIENT'S PROSTATE CANCER, RADIATION INJURY TO A STRUCTURE WHERE THE SEED WAS PLACED (OR AN ADJACENT STRUCTURE), AND POTENTIALLY AN INCREASED RISK OF SEED MIGRATION WITH ITS ATTENDANT COMPLICATIONS DEPENDING ON WHERE THE SEED MIGRATED TO. THERE IS NO EVIDENCE OF PATIENT HARM AS A RESULT OF THE EVENT EVALUATED IN THIS ASSESSMENT.