Description of Event or Problem · 0
WHILE USING THE LASER, SURGEON VERBALIZED THAT THE TIP OF THE LASER BROKE OFF IN THE PATIENT. THE SOUTHLAND LASER REP WAS PRESENT AT THE TIME AND ESCALATED THE SITUATION TO HIS SUPERVISOR. DEVICE WAS SEQUESTERED. THE PIECE OF LASER LEFT IN THE BODY WAS THEN RETRIEVED WITH A STONE BASKET AND VISUALIZED BY SURGEON THAT IT WAS TAKEN OUT OF THE BODY. SURGEON ALSO VERBALIZED THAT THIS ISN'T THE FIRST TIME THIS HAS HAPPENED WHERE THE TIP WAS FAULTY. [REDACTED] THE REP WAS INSTRUCTED BY THE SURGEON TO INVESTIGATE ON THE COMPANY'S END THE CAUSE. PER BIOMEDICAL ENGINEER EVALUATION: THE LASER FIBER TIP BROKE OFF, WAS DUE TO A FAULTY DISPOSABLE ITEM. THE FAULT WAS NOT THE LASER, BUT THE DISPOSABLE USED. THE LASER TECHNICIAN AND DISPOSABLE REP WERE PRESENT, AND THEY WERE AWARE OF THE LASER FIBER BEING FAULTY. THE MANUFACTURER IS AWARE (REP KNEW OF THE INCIDENT). THIS EVENT IS NOT THE LASER ITSELF. MANUFACTURER RESPONSE FOR LITHOTRIPSY FIBER, PROFLEX 273 LASER LITHOTRIPSY FIBER VAR. TRIMEDYNE (PER SITE REPORTER). UNDER INVESTIGATION.