Description of Event or Problem · 1
THE SURGEON HAD FIVE CASES SCHEDULED WITH INTENTIONS OF USING THE NEW ALLERGAN RAPID PORT EZ LAP BAND SYSTEM ON ALL OF THEM. THE FIRST AND SECOND CASES WERE COMPLETE WITH NO CONCERNS OR ISSUES. DIFFICULTIES AROSE IN THE FINAL THREE CASES. THE THIRD CASE INVOLVED (ALLERGAN COMPLAINT # (B) (6); PRODUCT B-2360; SERIAL NUMBER (B) (6). THIS CASE INVOLVED A FEMALE PT FOR A LAP BAND SYSTEM PLACED AROUND THE PT'S STOMACH APPROPRIATELY, THE PORT WAS THEN ATTACHED TO THE TUBING AND THE SURGEON "FIRED" THE PORT TO SECURE THE FOUR STAINLESS STEEL ANCHORS TO THE PT'S FASCIA. ONE OF THE ANCHORS DID NOT ATTACH PROPERLY AND THE PORT WOULD NOT DISLODGE FROM THE APPLIER. THE SURGEON ATTEMPTED TO FIRE AGAIN, BUT WAS UNSUCCESSFUL. IT WAS NOTED ONE OF THE ANCHORS HAD TWISTED TOWARDS THE MIDDLE OF THE PORT AND WOULD NOT ALIGN WITH ITS DESIGNATED "HOLE." SURGEON OPTED TO REMOVE PORT AND REPLACE WITH A COMPATIBLE SUTURABLE PORT FROM ALLERGAN. THE FOURTH CASE WAS ALLERGAN COMPLAINT (B) (6); PRODUCT B2360; SERIAL NUMBER (B) (6); FEMALE PT. THE SURGEON SUCCESSFULLY PLACED A LAPBAND AROUND THE PT'S STOMACH AND PROCEEDED TO ATTACH THE PORT. AFTER FIRING THE PORT TO ATTACH TO THE PT'S FASCIA, IT WAS NOTED ONE OF THE STAINLESS STEEL ANCHORS HAD NOT ATTACHED AND HAD IN FACT TWISTED TOWARDS THE MIDDLE OF THE PORT AND WOULD NOT ALIGN WITH THE DESIGNATED HOLE IT IS MEANT TO LOCK INTO. THE SURGEON OPTED TO REMOVE THE PORT AND REPLACED IT WITH AN OLDER MODEL COMPATIBLE WITH AN ALLERGAN SUTURABLE PORT. THE FIFTH CASE - ALLERGAN COMPLAINT # (B) (6) - MODEL B-2360 - S/N (B) (6) INVOLVED A FEMALE PT. THE SURGEON SUCCESSFULLY PLACED THE BAND PORTION OF THE SYSTEM, ATTACHED THE PORT AND WAS ATTEMPTING TO SECURE THE PORT TO THE PT'S FASCIA. AFTER FIRING THE PORT, IT WAS NOTED ONE OF THE ANCHORS HAD NOT SECURED TO THE FASCIA APPROPRIATELY. UPON INSPECTION, THE ANCHOR HAD TWISTED TOWARDS THE CENTER OF THE PORT AND WOULD NOT ALIGN WITH DESIGNATED HOLE IT LOCKS INTO. THE SURGEON REMOVED THE PORT AND REPLACED IT WITH AN ALLERGAN SUTURABLE PORT (SAME AS IN ABOVE 2 CASES). OF NOTE, IN ALL THREE CASES, THERE WAS NO INJURY TO THE PT. JUST A DELAY AND FRUSTRATION OF TROUBLE SHOOTING ISSUES. ALSO, IN ALL THREE CASES, IT WAS THE ANCHOR TO THE RIGHT OF THE TUBING (WHILE LOOKING AT BOTTOM OF THE PORT) THAT TWISTED. I REVIEWED ALLERGAN'S INSTRUCTIONS FOR USE AND THEY CLEARLY STATE TO HOLD FINGER PRESSURE UPON THE TOP OF THE PORT WHILE FIRING THE APPLIER. ALLERGAN REP CAME TO OUR FACILITY TO DISCUSS CONCERNS AND WHEN THIS WAS MENTIONED, HE INDICATED HE WAS UNAWARE OF THIS STEP AND WAS NOT TRAINED IN THIS MANNER, THEREFORE, OUR SURGEON WAS NOT EITHER. WE ARE UNSURE WHETHER THIS IS RELATED TO THE MALFUNCTIONS, BUT IT IS DEFINITELY WORTH NOTING AS IT WOULD SEEM THIS APPLIED PRESSURE WOULD ASSIST IN THE SECURING PROCESS. THE DEVICE REP CAME TO OUR FACILITY TO VISUALLY INSPECT DEVICES. WE WILL NOT RELEASE WITHOUT SIGNED AUTHORIZATION FROM PT.