{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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THIS UPGRADE WAS FROM THE STRYKER 1188 SERIES VIDEO SYSTEM. ONCE THE 1488 SERIES WAS INSTALLED, IT WAS NOTICED THAT DURING ARTHROSCOPIC PROCEDURES THE SCREEN WOULD LOSE ITS PICTURE FOR APPROXIMATELY 2-3 SECONDS EVERY COUPLE OF MINUTES WHEN THE STRYKER SERFAS ENERGY WAS USED. BOTH CLINICAL ENGINEERING AND OUR STRYKER ENDOSCOPY REP WERE NOTIFIED ABOUT THIS PROBLEM. CLINICAL ENGINEERING WAS NOTIFIED BY THE STRYKER REP THAT IT WAS A PROBLEM WITH THE COMBINATION OF THE \"OLDER\" ARTHROSCOPES AND THE NEWER 1488 SERIES CAMERA HEADS. DURING MULTIPLE DISCUSSIONS, IT WAS DETERMINED THIS WAS A KNOWN PROBLEM WITH STRYKER, HOWEVER THE OR WAS NEVER INFORMED OF THIS PROBLEM DURING THE EVALUATION PERIOD OR AFTER THE SYSTEM WAS PURCHASED. ABOUT FOUR WEEKS LATER, THIS PROBLEM WAS CONTINUING, WITH NO EFFORT TO FIX THE PROBLEM FROM STRYKER, EXCEPT THAT THEY SAY WE'RE WORKING ON A \"SOLUTION.\"WITH INCREASING FRUSTRATION FROM SURGEONS AND STAFF, THE DECISION WAS MADE TO PURCHASE THREE NEW ARTHROSCOPES TO CORRECT THE ISSUE IMMEDIATELY. (IT SHOULD BE KNOWN THAT THE OR HAD PLANNED TO PURCHASE ADDITIONAL SCOPES IN THE FUTURE AS THE VOLUME OF ORTHOPEDIC PROCEDURES HAS INCREASED). A QUOTE WAS OBTAINED FROM STRYKER AND THE ORDER WAS SUBMITTED ABOUT TWO WEEKS LATER TO PURCHASE THE NEEDED EQUIPMENT. ABOUT FIVE DAYS AFTER THE ORDER SUBMISSION, IN THE EVENING, THE OR WAS NOTIFIED THE ORDER FOR THE NEW LENSES WOULD NOT BE AVAILABLE WHEN NEEDED (A WEEK AFTER THE ORDER SUBMISSION DATE; WHICH WAS A LITTLE LESS THAN TWO DAYS FROM THE OR BEING NOTIFIED). THE DECISION WAS THEN MADE TO OBTAIN THE STRYKER 1188 SERIES CAMERA DRIVES AND CAMERAS FROM A SISTER HOSPITAL'S OR, WHICH HAD BEEN GIVEN TO THEM AS BACK-UP EQUIPMENT AFTER OUR OR UPGRADED THEIR EQUIPMENT. THE EQUIPMENT ARRIVED AT OUR OR THE DAY AFTER THE NOTIFICATION, SAFETY CHECKS WERE PERFORMED AND THE EQUIPMENT WAS INSTALLED INTO THE VIDEO SYSTEM TOWERS.ALSO ON THE DAY AFTER THE NOTIFICATION, AS AN EFFORT BY STRYKER, SCOPES WERE SENT IN FOR THE PROCEDURE, HOWEVER THE EQUIPMENT DID NOT MEET THE STANDARDS OF THE PHYSICIAN TO USE. IN FURTHER DISCUSSION WITH THE SALES REP, HE MENTIONED THAT THREE NEW ARTHROSCOPES WOULD BE SENT TO OUR OR FREE OF CHARGE. THESE ARTHROSCOPES ARRIVED FIVE DAYS AFTER THE DISCUSSION WITH THE SALES REP, AROUND 3:00PM.AS EXPLAINED BY STRYKER, THE CAUSE OF THE PROBLEM RESULTED IN METAL ON METAL CONTACT FROM THE CAMERA HEAD CONNECTING WITH THE ARTHROSCOPIC LENS. ENERGY WAS BEING TRANSFERRED FROM THE STRYKER SERFAS ENERGY TO THE CAMERA, CAUSING A POWER SURGE LIKE EFFECT AND INTERRUPTING THE VIDEO TRANSMISSION. THE NEW ARTHROSCOPES HAVE A PLASTIC HEAD WHICH COMES IN CONTACT WITH THE METAL CAMERA. THIS ELIMINATES THE PROBLEM WITH THE TRANSFER OF ENERGY BETWEEN THE TWO DEVICES." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }