Description of Event or Problem · 1
PATIENT WAS UNDERGOING ARTHROSCOPY. PHYSICIAN REQUESTED THE USE OF THE SLT LASER. SHARPLAN LASER SHEATH WITH LASER FIBER WAS ATTACHED TO THE SLT LASER. SHEATH WAS INSERTED VIA PORT HOLE INTO THE PATIENT'S RIGHT KNEE JOINT. ALOUD CRACK WAS HEARD. TIP OF SHEATH APPARENTLY BROKE OFF AND WAS LODGED IN THE PATIENT'S KNEE JOINT. THE PHYSICIAN WAS UNSUCCESSFUL IN RETREIVING THE TIP OF THE SHEATH VIA ARTHROSCOPY. PATIENT REQUIRED AN ARTHROTOMY IN ORDER TO RETREIVE THE TIP. PATIENT WAS DISCHARGED WITHOUT INCIDENT FOLLOWING ARTHROTOMY. EXAMINATION OF THE SHEATH REVEALED THAT TIP BROKE OFF AT POINT WHERE END PIECE IS SCREWED ON IN PLACE. TIP PIECE 1.5 CM. IN LENGTH. (QUESTION #34 - SLT LASER = SLT ENTERPRISES)DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.