BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRAPULSE 5000C LASER

    MDR report key: 2180196 · Received July 27, 2011

    Report

    Report Number
    1720381-2011-00035
    Date Received
    July 27, 2011
    Date of Event
    February 15, 2011
    Report Date
    July 25, 2011
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K963339
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS MDR IS TO RESPOND TO THE FOLLOW-UP REQUEST LETTER THAT WAS ISSUED TO LUMENIS REGARDING THE SUBMITTAL OF VOLUNTARY MEDWATCH (B)(4). FDA'S OBSERVATIONS ARE STATED BELOW, FOLLOWED BY LUMENIS' RESPONSE. THE REPORTER INDICATES THAT THE DIFFICULTIES ENCOUNTERED BY THE LASER USERS ULTIMATELY STEMMED FROM A REPRESENTATIVE FROM THE LASER RENTAL FIRM WHO " ... CONNECTED THE SUPPORT ARMS FOR THE LASER HEAD BACKWARD, HENCE THE ABILITY TO ROTATE THE LASER WAS INHIBITED". BASED ON THE DESCRIPTION OF THE EVENTS IN THE REPORT, AND ANY FOLLOW-UP WITH THE HOSPITAL OR RENTAL AGENCY WHICH MAY HAVE BEEN CONDUCTED, PLEASE EXPLAIN THE SUSPECTED ROOT CAUSE OF THE PROBLEM. PROVIDE EXPLANATIONS AND/OR DRAWINGS AS NECESSARY TO ILLUSTRATE HOW THIS ERROR MAY HAVE TAKEN PLACE. AN INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED BY LUMENIS. DURING THE INVESTIGATION, LUMENIS CONTACTED A REPRESENTATIVE OF (B)(4) LASER, THE CURRENT OWNER OF THE SUBJECT DEVICE. LUMENIS WAS INFORMED BY THE (B)(4) REPRESENTATIVE THAT THE SUBJECT DEVICE HAD BEEN PURCHASED FROM A THIRD PARTY VENDOR AND NOT FROM LUMENIS DIRECTLY. ADDITIONALLY, THE REPRESENTATIVE REPORTED THEY WERE PRESENT DURING THE REPORTED EVENT. THE (B)(4) REPRESENTATIVE STATED THAT THE LASER WAS PREPARED FOR THE PROCEDURE WITHOUT INCIDENT, AND FURTHERMORE DESCRIBED THAT AT THE START OF THE PROCEDURE, LASER-ASSISTED COLPOSCOPY, THE PHYSICIAN REQUESTED A DIFFERENT MICROSCOPE THAN WAS INITIALLY CONNECTED TO THE SUBJECT DEVICE. THE (B)(4) LASER REPRESENTATIVE EXPRESSED THAT DURING THE EXCHANGE OF THE MICROSCOPES BY THE HOSPITAL STAFF, THE LASER ARM WAS MOVED OUT OF THE FIELD. WHEN THE LASER ARM WAS RETURNED TO THE FIELD, THE DOCTOR THEN NOTED THAT THEY WERE "NOT HAPPY WITH THE LASER" AS WAS STATED ON THE SUBJECT VOLUNTARY MEDWATCH (B)(4). THE RECORD ALSO STATES THAT THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO ADVERSE EVENT WAS REPORTED TO HAVE OCCURRED DURING THE PROCEDURE BY (B)(4) OR THE INITIAL REPORTER. FOLLOWING THE PROCEDURE, IT WAS NOTED BY THE (B)(4) REPRESENTATIVE THAT THE LASER ARM HAD BEEN INADVERTENTLY FLIPPED WHEN IT WAS MOVED OUT OF THE FIELD BY THE HOSPITAL STAFF TO EXCHANGE THE MICROSCOPES. THE LASER ARM IS THE DELIVERY DEVICE FOR THE LASER ENERGY. THE ARM IS ARTICULATED AND DESIGNED FOR UNINHIBITED MOTION. THE ARM IS CLEARLY MARKED WITH INDICATOR ARROWS TO INDICATE THE CORRECT POSITIONING OF THE ARM. THE ARM WILL FUNCTION WHETHER IT IS IN THE UPRIGHT OR FLIPPED POSITION; HOWEVER, AS STATED IN THE ATTACHED PAGES FROM THE SUBJECT DEVICE LUMENIS OPERATOR MANUAL PAGE 5-6, "AN IMPROPERLY ORIENTATED ARTICULATED ARM CAN CAUSE A REDUCTION IN AIMING BEAM ILLUMINATION INTENSITY ON SOME OPTIONAL DELIVERY SYSTEMS." FROM THE INVESTIGATION, IT APPEARS THE HOSPITAL STAFF FAILED TO ASSURE THE ARM WAS IN THE CORRECT POSITION AFTER THE REPLACEMENT MICROSCOPE WAS SET-UP. AN EVALUATION OF THE REPORTED EVENT DETAILS BY A LUMENIS TECHNICAL SPECIALIST CONCLUDED THAT THE ROOT CAUSE OF THE EVENT REPORTED IN THE SUBJECT VOLUNTARY MEDWATCH REPORT, WAS OPERATOR ERROR; FAILURE ON THE PART OF THE DEVICE OPERATOR AND HOSPITAL STAFF TO OBSERVE THE MARKED ARROWS ON THE DEVICE ARM TO DETERMINE CORRECT ORIENTATION PRIOR TO TREATMENT. LUMENIS HAD DETERMINED THAT THE EVENT WAS NOT A REPORTABLE EVENT AS NEITHER A SERIOUS INJURY NOR DEVICE MALFUNCTION OCCURRED. THE REPORTED EVENT WAS THE CAUSED BY OPERATOR ERROR. NO FOLLOW-UP MDR HAD BEEN DETERMINED TO BE REQUIRED; HOWEVER, LUMENIS DETERMINED THAT PRUDENCE DICTATES A RESPONSE TO CLARIFY THE DETAILS OF THE INITIAL REPORT. ARE THERE NORMALLY ANY SAFEGUARDS, PHYSICAL LOCKOUTS, OR OTHER WARNINGS PRESENT WHICH ARE MEANT TO PREVENT THE SCENARIO DESCRIBED? IF SO, EXPLAIN HOW THEY WERE CIRCUMVENTED OR IGNORED. AN EVALUATION OF THE REPORTED EVENT DETAILS BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT CONCLUDED THE EVENTS WERE REPORTED ERRONEOUSLY BY THE USER FACILITY ON THE ASSOCIATED MEDWATCH. THE EXPERT NOTED IT IS IMPOSSIBLE TO CONNECT THE LASER ARM "BACKWARD" AS WAS ORIGINALLY REPORTED ON THE ASSOCIATED MEDWATCH. THE ARM IS CLEARLY MARKED TO INDICATE ITS CORRECT ORIENTATION AND IS ILLUSTRATED IN DEVICE LABELING, PAGE 5-6 AND 5-7, AS ORIGINALLY SHIPPED BY LUMENIS. IT APPEARS THE HOSPITAL STAFF FAILED TO OBSERVE THE ORIENTATION OF THE INDICATOR MARKERS PRIOR TO THE PROCEDURE. ARE THERE ANY FURTHER MEASURES WHICH CAN BE IMPLEMENTED TO PREVENT A SCENARIO SUCH AS THAT DESCRIBED? OBSERVANCE OF THE PROPER ORIENTATION OF THE ARTICULATED ARM AS ILLUSTRATED IN THE DEVICE LABELING PROVIDED WITH THE DEVICE, INCLUDED WITH ORIGINAL PROVISION OF THE SUBJECT DEVICE, WOULD HAVE PREVENTED THE SCENARIO AS INVESTIGATED BY LUMENIS. PLEASE EXPLAIN THE NATURE OF ANY RELATIONSHIP BETWEEN THE LASER RENTAL AGENCY (REPORTEDLY (B)(4) LASER) AND YOUR COMPANY. IS TRAINING ON YOUR PRODUCTS PROVIDED TO THIS RENTAL COMPANY? LUMENIS HAS NO RELATIONSHIP TO THE LASER RENTAL COMPANY, (B)(4) LASER. THE SUBJECT DEVICE COHERENT 5000C CO2 SURGICAL LASER, SN (B)(4), WAS NOT PURCHASED FROM LUMENIS DIRECTLY. THE SUBJECT DEVICE MODEL 5000C CO2 LASER IS NO LONGER MANUFACTURED BY LUMENIS. A REVIEW OF SERVICE RECORDS FOR THE SUBJECT DEVICE FOUND THAT THE SUBJECT DEVICE WAS LAST SERVICED BY LUMENIS ON 01/11/2008, AS NOTED IN THE DOCUMENTED MAINTENANCE RECORDS OF THE ORIGINAL PURCHASER OF THE LASER SYSTEM. LUMENIS HAS NO RECORD OF THE SALE OR TRANSFER OF THE DEVICE FROM THE ORIGINAL PURCHASER TO (B)(4) LASER AND WAS FULLY UNAWARE OF SUCH AN EVENT; SUBSEQUENTLY, NO TRAINING FOR THE SUBJECT DEVICE WAS REQUESTED OR PROVIDED BY LUMENIS TO (B)(4) LASER WITH THE LATTER PROCEEDING FULLY ON THEIR OWN ACCORD. SHOULD YOU REQUIRE FURTHER INFORMATION, PLEASE DO NOT HESITATE TO CONTACT LUMENIS, INC.

    Description of Event or Problem · 1

    IT WAS REPORTED ON VOLUNTARY MED WATCH (B)(4). THAT THE PHYSICIAN REQUESTED A DIFFERENT MICROSCOPE IN THE OPERATING ROOM PRIOR TO THE PROCEDURE. THE PHYSICIAN NOTED THAT THEY WERE UNHAPPY WITH THE VISUAL FIELD BUT IT DID NOT AFFECT THEIR ABILITY TO COMPLETE THE PROCEDURE. THE MEDWATCH STATES THAT THERE WAS NO PATIENT ADVERSE EVENT. IT WAS FURTHER REPORTED THAT DURING THE EXCHANGE OF THE MICROSCOPES, THE LASER ARM WAS INVERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAPULSE 5000C LASER CARBON DIOXIDE SURGICAL LASER GEX LUMENIS, INC. 5000C

    Patients

    Seq Age Sex Outcome Treatment
    1