Description of Event or Problem · 1
THE PT WAS SCHEDULED FOR A LAPBAND PORT REVISION. THE PT ORIGINALLY HAD STANDARD AP LAPBAND WITH A RAPID PORT EZ SYSTEM PLACED LAST YEAR. THE PT HAD RECENTLY BEGUN EXPERIENCING ISSUES WITH HER LAPBAND AND THE CLINIC STAFF WERE NOT ABLE TO ACCESS THE PORT WHICH LED TO AN INABILITY TO ADJUST THE BAND BY ADDING AND REMOVING SALINE. DURING THE PROCEDURE, THE SURGEON IDENTIFIED THE PORT AND NOTED THE TUBING HAD MULTIPLE LOOPS WHICH APPEARED TWISTED. THE SURGEON ALSO NOTED THE PORT WAS SEQUENTIALLY FLIPPING FREELY IN ITS POCKET, AND WAS NOT SECURED AGAINST THE MUSCLE FASCIA BY MEANS OF THE FOUR STAINLESS STEEL RETENTION "HOOKS" WHICH DEPLOY WHEN THE DEVICE IS FIRED DURING INITIAL PLACEMENT. SURGEON REMOVED THE PORT AND A NEW SUTUREABLE ACCESS PORT (ALLERGAN B-2101) WAS PLACED ON THE EXISTING LAP BAND SYSTEM. THE PATHOLOGY IMAGES SHOW THE EXPLANTED PORT TO HAVE ALL FOUR RETENTION "HOOKS" IN THE LOCKED/CLOSED POSITION WHICH WOULD SUGGEST THEY HAD TORN AWAY FROM THE FASCIA. OUR HOSPITAL HAS PREVIOUSLY REPORTED CONCERNS WITH THIS DEVICE AS WELL AS CONCERN WITH THE PHYSICIAN EDUCATION REGARDING PLACEMENT OF THIS DEVICE. THE PT THIS REPORT RELATES TO TOLERATED THE PROCEDURE WELL, WAS SENT TO PACU FOR RECOVERY AND WAS DISCHARGED HOME AS EXPECTED. SURGEON NO LONGER USES THE EXPLANTED PORT SYSTEM. HE RETURNED TO USING THE SUTURABLE ONES BY THIS MANUFACTURER. THE MFR RESPONSE WAS WE DISCUSSED THE ISSUES AND CONCERNS WITH THE PRODUCT REP. WE ARE UNSURE WHAT TYPE OF ADDITIONAL TRAINING THEY HAVE SUPPLIED TO THEIR REPS.