OPMI PENTERO

Description of Event or Problem

THIS IS CASE TWO OF THREE REPORTED CASES INVOLVING THE SAME SURGEON AND THE SAME MICROSCOPE. IT WAS REPORTED THAT A PATIENT HAD A SECOND-DEGREE BURN ABOUT THE SIZE OF A DIME ON THE UPPER RIGHT AREA OF THE INCISION IMMEDIATELY AFTER A LUMBAR MICRODISCECTOMY PROCEDURE USING AN OPMI PENTERO MICROSCOPE. THE BURN WAS TREATED WITH SILVER SULFADIAZINE CREAM. ADDITIONAL INFORMATION REPORTED: THE PROCEDURE TOOK TWO HOURS AND 15 MINUTES; THE INCISION WAS COVERED WITH VI CLEAR DRAPE; THE WOUND WAS IRRIGATED WITH BACITRACIN SOLUTION; THE MICROSCOPE LIGHT INTENSITY WAS SET TO 100% AT A WORKING DISTANCE OF 10-15 INCHES WITH THE DURATION DESCRIBED AS "VARIABLE"; THE SURGEON HAD TRAINING AND WORK EXPERIENCE WITH THE MICROSCOPE.

Additional Manufacturer Narrative

EVALUATION: A FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE INSPECTION, INCLUDING LIGHT SETTING FUNCTIONS, AND DETERMINED THE SYSTEM TO BE FULLY FUNCTIONAL WHEN FUNCTIONS WERE ACTIVATED. THE FSE NOTED: INTELLIGENT MANAGEMENT OF LIGHT INTENSITY CONTROL FEATURE WAS TURNED OFF; AUTOMATIC ZOOM CONTROL AND AUTOMATIC IRIS CONTROL NOT ACTIVATED; SURGEON'S PERSONAL DEFAULT SETTINGS WERE 80% LIGHT INTENSITY AND 100% LIGHT WARNING THRESHOLD; 100% INTENSITY USED DURING EVENT. THE USER MANUAL RECOMMENDS A WARNING THRESHOLD VALUE OF 25% (FACTORY CONFIGURED). SETTING THE WARNING THRESHOLD TO 100% RESULTS IN NO LIGHT INTENSITY WARNING. THE USER MANUAL STATES: "WHEN WORKING AT MAXIMUM MAGNIFICATION...PAY PARTICULAR ATTENTION TO THE SET LIGHT INTENSITY TO PREVENT BURNS"; "THE SELECTED INTENSITY OF THE LIGHT SOURCE IS A MAJOR FACTOR FOR THE RISK OF INJURY. IT SHOULD ALWAYS BE SET TO THE MINIMUM REQUIRED FOR THE SURGICAL PROCEDURE TO BE PERFORMED", LONG SURGICAL PROCEDURE INCREASES THE RISK OF INJURY"; MOST BURNS AFFECT THE SKIN AROUND THE INCISION". SITE CONTACT: (B)(6), RESOURCE MANAGER, (B)(6).