(B)(6) HOSPITAL CALLED TO REPORT AN INCIDENT DURING AN INTERSTITIAL PROSTATE IMPLANT, WHEREBY AFTER TREATMENT, IT WAS DISCOVERED THE TIP OF A FLEXI-GUIDE NEEDLE HAD BROKEN OFF. WE ARE THE MFR OF THE FLEXI-GUIDE NEEDLE. DURING SURGERY THE PT WAS UNDER ANESTHESIA AND WAS IMPLANTED WITH 18 INDIVIDUAL FLEX-GUIDE PLASTIC NEEDLES WHICH ARE THEN CONNECTED TO AN HDR AFTERLOADER TO ADMINISTER RADIATION DOSES. THE PT WOKE UP WHILE UNDER ANESTHESIA AND THRASHED AROUND, POSSIBLY DISPLACING THE NEEDLES. THE PT WAS RE-ANESTHESIZED AND PER STANDARD PROCEDURE, THE TREATMENT PLAN WAS REVISED OR VERIFIED AND THE NEEDLES WERE ADJUSTED PER THE PLAN. A DUMMY SOURCE RUN WAS PERFORMED THROUGH EACH OF THE 18 CHANNELS WITH NO INCIDENT. THE RADIATION WAS ADMINISTERED AS PLANNED IN CHANNEL 1. WHEN MOVING TO CHANNEL 2, WHEN THE DUMMY SOURCE WAS RUN OUT, THIS TIME IT HAD AN ERROR CODE NOTHING THE LUMEN TOO LONG. THE NEEDLE WAS RE-ADJUSTED AND MEASURED WITH A LENGTH GAGE WITH NO PROBLEM. CHANNEL 2 WAS THEN TREATED WITHOUT INCIDENT, AS WELL AS THE OTHER 16 CHANNELS. BECAUSE OF THE PREVIOUS ERROR CODE, THE NEEDLE IN CHANNEL 2 WAS REMOVED FIRST. IT WAS THEN THE OPERATING ROOM STAFF...
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Patient 1
THE TIP OF THE NEEDLE HAD BROKEN OFF RIGHT WHERE THE NEEDLE MEETS THE TEMPLATE, OUTSIDE THE BODY. WHEN QUESTIONED, THE HOSPITAL STAFF STATED WHEN THE LENGTH CHECK WAS DONE WITH THE LENGTH GAGE, IT DID NOT HAVE ANY RESIDUE OR CONTAMINANTS EVIDENT ON THE GAGE. THIS INDICATES THAT WHILE IN THE BODY, THE NEEDLE WAS INTACT; IF NOT, FLUID WOULD HAVE BEEN EVIDENT WHICH COULD HAVE LEAKED INSIDE THE LUMEN OF THE NEEDLE THROUGH THE BROKEN END. HOWEVER, THIS CONDITION WAS NOT EVIDENT PER THE HOSPITAL REPORT. THE PT WAS TREATED NORMALLY PER THE PLAN AND PT SAFETY WAS NOT AT RISK. ONE POSSIBLE EXPLANATION IS THAT UPON REMOVAL, THE NEEDLE MIGHT HAVE BEEN BENT AGAINST THE RIGID TEMPLATE WHILE STILL INSTALLED IN THE TEMPLATE, CAUSING THE TIP TO BREAK OFF. NOTE: THE HOSPITAL STAFF WAS UNABLE TO RELAY TO US THE LOT NUMBER OF THE NEEDLES USED. HOWEVER THE LAST LOT OF 0912 NEEDLES WE SHIPPED TO THIS CUSTOMER WAS # 130628-19, WITH AN EXPIRATE DATE OF 5/17.