BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTA DUET LED

    MDR report key: 9613318 · Received January 21, 2020

    Report

    Report Number
    1720381-2019-00013
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 21, 2020
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    UDI-DI
    00729010914331
    PMA / PMN Number
    K051944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ON 12/23/2019 THE LUMENIS (B)(4) WAS INFORMED THAT ON (B)(6) 2019 DURING AN OS CAPSULOTOMY, A PATIENT EXPERIENCED DECREASED VISION IN THE LEFT EYE FROM POSSIBLE DAMAGE TO THE MACULA. AT PC INTAKE, IT WAS STATED THAT THEY SELECTED SLT MODE AND THE UNIT SWITCHED TO YAG ON IT'S OWN AND FIRED ON ITS OWN. LATER, IN THE INCIDENT FORM DR (B)(6)STATED THAT THE LASER WAS SET TO YAG. OVER SEVERAL CONVERSATIONS DR (B)(6) STATES "THE PATIENT'S RETINA WAS NORMAL WITH 20/50 VISION PREOPERATIVELY. THE PATIENT HAD AN ENTIRELY NORMAL EXAM OTHER THAN PCO PRIOR TO THE LASER PROCEDURE. THERE WAS NO EVIDENCE OF A PVD OR SUB RETINAL HEMORRHAGE PRIOR TO USING YOUR LASER. AFTER FOUR PULSES TITRATED TO MAXIMUM POWER STARTING FROM 1.1 MJ, I ABANDONED YOUR LASER AND USED APPROXIMATELY 22 PULSES WITH A COHERENT LASER AT MY USUAL POWER SETTING. THE PATIENT NOTED IMMEDIATE FLOATERS AND AFTER IMAGE SPOTS THAT I ASSUMED WERE NORMAL CAPSULE REMNANTS BUT WHEN THEY PERSISTED SHE WAS REFERRED. LASER SETTINGS WERE; NO CONTACT LENS, SINGLE PULSE, 125 MICRON POSTERIOR OFFSET, 3.5 MJ. THE RIGHT EYE HAD SIMILAR SURGERY AND POST SURGICAL YAG WITH MY OLD LASER WITHOUT INCIDENT. SHE NOTED A DRAMATIC DIFFERENCE BETWEEN THE TWO LASER PROCEDURES." PER THE INCIDENT FORM, NO INTERVENTION WAS REQUIRED DURING THE INCIDENT. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST, DR (B)(6) FOR A FOLLOW UP EXAMINATION. NEXT VISIT TO DR (B)(6) IS SCHEDULED FOR EARLY (B)(6) 2020. AFTER THE INITIAL SYSTEM HISTORY (SEE COMPLAINT DESCRIPTION FOR DATES AND EVENTS) SERVICE EXPERT (B)(4) EXAMINED THE SYSTEM ON DEC 10 UNDER WORK ORDER (B)(4) FOR THE FOLLOWING COMPLAINT; "(B)(4) REPORTED THAT THE SYSTEM IS NOT FIRING AS USUAL. NO ERROR CODES/MESSAGES". HIS NOTES FROM THE VISIT WERE; "REPORTED FIRING INCONSISTENT. FOUND AIMING BEAMS NOT COMING TOGETHER IN YAG MODE. REALIGNED AIMING BEAMS TO YAG. VERIFIED CALIBRATION AND OPERATION. PM SYSTEM. SYSTEM READY FOR USE. DEMO." FURTHER CLARIFICATION WITH THE SERVICE ENGINEER RESULTS IN THE FOLLOWING INFORMATION; HE INSTALLED THIS DEMO SYSTEM A WEEK BEFORE THE CASE OCCURRED AND SEVERAL DOCTORS HAD WORKED WITH THE SYSTEM WITH NO PROBLEM. ON THE INSTALLATION DAY HE ALIGNED THE SYSTEM AND ALL WENT SMOOTHLY WITH NO PROBLEMS. AFTER A WEEK HE CAME BACK DUE TO THE SAFETY COMPLAINT AND THE SYSTEM ALIGNMENTS WERE A BIT OFF. IT WASN'T SUPPOSED TO BE OFF AFTER A WEEK - THAT IS WHY HE USED THE SENTENCE "THE SYSTEM WAS BUMPED", MEANING THEY MOVED IT AND PROBABLY HIT A WALL THAT MADE THE ALIGNMENT TO MOVE. THE TWO AIMING BEAMS WERE NOT COLLIDED, ONE WAS OFF AND NEEDED TO BE ALIGNED NOT SOMETHING ABNORMAL WE SEE THIS ALIGNMENTS ALL THE TIME (BUT NOT AFTER A WEEK). THE AIMING BEAM WAS OFF BY FEW MM 5-10. AFTER HE DID THE ALIGNMENTS THE SYSTEM HAVE BEEN USED COUPLE MORE TIMES WITH NO PROBLEMS. THE SYSTEM THEN MOVED TO ANOTHER SITE AND WAS SOLD TO THEM. (THEY WERE OBVIOUSLY HAPPY WITH THE SYSTEM). TO SUMMARIZE, DESPITE THE SLIGHT MISALIGNMENT THE SYSTEM WAS FOUND TO BE FUNCTIONING PROPERLY AND NO MALFUNCTION WAS DETECTED. A REVIEW OF THE SLT SELECTA DUET SYSTEM (GAS910000LED SERIAL NUMBER (B)(4)) DHR RECORDS SHOWED THAT THE SYSTEM WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. THE SYSTEM PASSED ALL TESTING AND MET ALL LUMENIS SPECIFICATIONS PRIOR TO THE RELEASE FOR SALE. THE MANUFACTURE DATE WAS 12/29/2018. A REVIEW OF THE SERVICE HISTORY FOR THE SUBJECT SYSTEM FINDS NO OTHER REPORTS OF FUNCTIONAL ISSUES OR PROBLEMS IN THE APPROXIMATELY 13-MONTH HISTORY OF THE UNIT. A THOROUGH INVESTIGATION AND SUBSEQUENT CLINICAL REVIEW OF THIS ADVERSE EVENT RESULTED IN SEVERAL OBSERVATIONS AS TO POTENTIAL CAUSES, EACH OF WHICH WAS RULED OUT AS A LIKELY CAUSE. SEE (B)(4) FOR COMPLETE DETAILS OF ANALYSIS. GIVEN ALL OF THE ABOVE, WE ARE UNABLE TO GIVE A PLAUSIBLE EXPLANATION TO THIS INCIDENT. BEYOND THE MISALIGNMENT (WHICH CANNOT EXPLAIN THE INCIDENT), MALFUNCTION OF THE DEVICE WAS COMPLETELY RULED OUT. HOWEVER, SOME QUESTIONS REMAINED THAT COULD SUGGEST A HUMAN FACTOR/ERROR BUT SUBSEQUENT ATTEMPTS TO CONTINUE DISCUSSION WITH THE TREATING DOCTOR WENT UNANSWERED. AS SUCH, LUMENIS WILL REPORT THIS EVENT TO THE FDA PER THE DECISION TREE DETERMINATION. LUMENIS WILL CONTINUE TO MONITOR THE EVENT AND SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. LUMENIS IS CLOSING THIS COMPLAINT AT THIS TIME, COMPLAINT TRENDING WILL CONTINUE TO MONITOR PER GLOBAL COMPLAINT HANDLING SOP ((B)(4)) AND PER POST MARKETING SURVEILLANCE PROCEDURE ((B)(4)).

    Description of Event or Problem · 1

    ON (B)(6) 2019 DURING AN OS CAPSULOTOMY, A PATIENT EXPERIENCED DECREASED VISION IN THE LEFT EYE FROM POSSIBLE DAMAGE TO THE MACULA. AT PC INTAKE, IT WAS STATED THAT THEY SELECTED SLT MODE AND THE UNIT SWITCHED TO YAG ON IT'S OWN AND FIRED ON ITS OWN. IN THE INCIDENT FORM DR (B)(6) STATED THAT THE LASER WAS SET TO YAG. (B)(4) WENT IN TO CHECK THE UNIT AND SAID IT LOOKED LIKE SOMEONE BUMPED THE UNIT - AIMING BEAMS WERE OUT OF ALIGNMENT IN YAG MODE (SEE WO (B)(4)). REALIGNED AIMING BEAMS. EVERYTHING ELSE CHECKED OUT FINE. THE SYSTEM WAS A DEMO UNIT THAT WAS SUBSEQUENTLY PACKED UP AND SHIPPED TO ANOTHER CUSTOMER WHO REPORTED HAVING NO ISSUES WITH THE SYSTEM. THE PATIENT WAS REFERRED TO A RETINA SPECIALIST FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75941 SELECTA DUET LED POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE GEX GEX LUMENIS, INC. SELECTA DUET LED 00729010914331

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other