Description of Event or Problem · 1
SURGICAL PROCEDURE: RIGHT EXTRACTION OF CATARACT WITH IMPLANT OF LENS. THE PT EQUIPMENT WAS PREPARED AND CHECKED IN THE USUAL MANNER PRIOR TO SURGERY. THE EQUIPMENT CHECK WAS SATISFACTORY FOR THIS CASE. BEFORE INITIATION OF SURGERY, IT WAS NOTED THAT THE BLUE PLASTIC HANDPIECE SLEEVE WAS TORN, SO IT WAS REPLACED. AT THE BEGINNING OF THE PHACOEMULSIFICATION PROCESS OF THIS SURGERY, THE DR PULLED THE HANDPIECE OUT OF THE EYE STATING THE TIP WAS LOOSE. UPON REMOVAL OF THE BLUE PLASTIC COVER, THE TIP, WAS SEEN TO BE BROKEN, SO IT WAS REPLACED. THE SURGICAL PROCEDURE CONTINUED AND DR STATED THE TIP WAS CREATING TOO MUCH HEAT AND NOTED A WHITE AREA AROUND THE INSERTION SITE. THE AREA WAS IRRIGATED WITH SALINE. THE HANDPIECE WAS TAKEN OFF THE FIELD. DR CHOSE TO COMPLETE THE SURGICAL PROCEDURE UTILIZING AN EXTRACAPSULAR APPROACH. DR STATED THAT HE FELT THAT THE TIP CAUSED A BURN TO THE INCISION AREA. UPON REVIEW OF THE TECHNIQUE, DR STATED THAT HE THOUGHT THE INCISION SIZE, UTILIZING A 3.0 MM KNIFE WAS TOO SMALL FOR THE TIP DIAMETER, AND THAT THIS INCISION SIZE DID NOT ALLOW FOR THE USUAL FREE-FLOW OF IRRIGATION FLUID THAT COOLS THE TIP DURING NORMAL PHACOEMULSIFICATION. THIS SAME PROCEDURE WAS REPEATED ON A SUBSEQUENT PT UTILIZING A 3.2 MM INCISION SITE AND NO DIFFICULTY WAS NOTED. THE CO WAS NOTIFIED OF THE DIFFICULTIES. THE HANDPIECE TOOL AND BROKEN TIP ARE TO BE SENT FOR EVALUATION. MFR'S PRODUCT SAFETY DEPARTMENT WAS NOTIFIED. A NEW HANDPIECE IS TO BE SUPPLIED. THE MAIN POWER UNIT TO BE INSPECTED BY MFR'S FIELD SERVICE.