BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANDELA GENTLEMAX LASER SYSTEM

    MDR report key: 6471602 · Received April 7, 2017

    Report

    Report Number
    1218402-2017-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    February 10, 2017
    Report Date
    April 6, 2017
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K112715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD INITIALLY CALLED (B)(4) SERVICE DEPARTMENT ON 02/14/2017 TO REPORT OF A FAULT/ERROR MESSAGE ON THE LASER THAT WOULD NOT ALLOW THE DEVICE TO OPERATE WITH 6-18 MM SPOT SIZE DELIVERY SYSTEM (DS). THE CUSTOMER WAS ADVISED ON THE CALL TO GET A NEW DELIVERY SYSTEM OF THE 6-18 MM SPOT SIZE AS IT WAS FAULTY AND NOT FUNCTIONAL ANYMORE. THE DS WAS SHOWING A LOW TRANSMISSION ERROR WHICH RENDERS IT UNUSABLE AND INOPERABLE FOR TREATMENT. A SERVICE ENGINEER VISITED THE ACCOUNT ON 02/22/2017 TO EVALUATE THE DEVICE BECAUSE OF A SERVICE CALL (NON-INJURY) AND ONCE AGAIN RECOMMENDED THAT THE CUSTOMER BUY A NEW DELIVERY SYSTEM AS THE CURRENT ONE WAS FAULTY AND UNREPAIRABLE. THE DEVICE WAS WORKING WITHIN (B)(4) SPECIFICATIONS BUT THE 6-18MM SPOT SIZE DELIVERY SYSTEM (DS) WAS FAULTY. IT WAS SHOWING A LOW TRANSMISSION ERROR WHICH MAKES IT INOPERABLE. THE LASER DEVICE WAS FUNCTIONING AS INTENDED AND WOULD NOT LET THE FAULTY DELIVERY SYSTEM TO BE USED FOR TREATMENT. THE CUSTOMER ORDERED A NEW DELIVERY SYSTEM WHICH WAS DELIVERED ON 02/24/2017. A NEW DELIVERY SYSTEM WAS SHIPPED TO THE CUSTOMER ON 02/24/2017. A SECOND NEW DELIVERY SYSTEM WAS ALSO SENT TO THE CUSTOMER ON 02/27/2017 WHEN THEY REPORTED THAT THE NEW ONE SHIPPED ON 02/24/2017 WAS FAULTY. THE SERVICE ENGINEER VISITED THE ACCOUNT ON 03/01/2017; EVALUATED THE DEVICE AGAIN AND REPLACED THE CLUSTER CONNECTOR, AND ASSOCIATED PARTS; CALIBRATED YAG, AND ALEX HEADS AND. VERIFIED PARAMETERS AND THAT THE LASER MEETS ALL (B)(4) SPECIFICATIONS. THERE WAS NOTHING WRONG WITH THE DELIVERY SYSTEM BUT RATHER THE CONNECTION TO THE DEVICE ITSELF WAS LEAKING CRYOGEN AT THE POINT WHERE IT CONNECTS TO THE DEVICE. THE CUSTOMER LATER CALLED (B)(4) ON 03/08/2017 TO REPORT OF INJURIES THAT HAD OCCURED PRIOR TO INSTALLATION OF THE NEW TWO DS SYSTEMS THE CUSTOMER SENT THE OLD DELIVERY SYSTEM ( SERIAL #(B)(4)) BACK TO THE MANUFACTURER. THE RETURNED DELIVERY SYSTEM WAS ORIGINALLY MANUFACTURED ON 7/29/2009. THIS SYSTEM WAS NOT OPERATIONAL. MANUFACTURER WAS UNABLE TO CALIBRATE IT AND AS IS CUSTOMER WOULD NOT HAVE BEEN ABLE TO USE THIS DS FOR TREATMENT. ·THE LASER WAS MANUFACTURED AND INSTALLED IN 2011. THE DELIVERY SYSTEM WAS MANUFACTURED IN 2009. OUR SALES AND SERVICE RECORDS INDICATE THE DEVICE WAS SOLD WITH A DELIVERY SYSTEM (SERIAL # (B)(4)) DIFFERENT FROM THE ONE REPORTED IN THE INCIDENT. THE DELIVERY SYSTEM (DS) REPORTED IN THE INCIDENT WAS SOLD TO A DIFFERENT ACCOUNT IN (B)(6) IN 2009 AND THERE ARE NO SERVICE RECORDS SINCE IT WAS SOLD. THE REPORTING ACCOUNT HAS NOT HAD ANY SERVICE CALLS ON THEIR DELIVERY SYSTEM SINCE IT WAS PURCHASES AND HAVE NEVER ORDERED ANY REPLACEMENTS. BASED ON OUR INVESTIGATION, THE DS PROVIDED BY THE ACCOUNT WAS MOST LIKELY BOUGHT OR ACQUIRED USED FROM A THIRD PARTY. (B)(4) TRACKS ALL SHIPMENTS AND LASERS SOLD TO CUSTOMERS. ALL MAINTENANCE RECORDS FOR LASERS AND DS ARE TRACKED BY (B)(4). THE DS AS SENT TO THE MANUFACTURER WAS UNUSABLE AND THEREFORE THERE WAS NO WAY TO CAUSE INJURIES SINCE THE SYSTEM WILL NOT CALIBRATE. THE DEVICE HAD BEEN EVALUATED MULTIPLE TIMES AROUND THE TIME THE INJURIES HAPPENED AND THE DEVICE PROVIDED FOR EVALUATION DOES NOT MATCH THE ONE EVALUATED ON THE FIELD. THE INCIDENTS WERE NOT REPORTED AT THE TIME DURING THE EVALUATIONS BUT A WEEK AFTER ALL THE SERVICE CALLS WERE COMPLETED. (B)(4)DOES NOT SELL OLD DELIVERY SYSTEMS WITH NEW LASERS. THIS DS WAS MOST LIKELY OBTAINED FROM A THIRD PARTY ALREADY USED AND HAD NEVER BEEN SERVICED BY A (B)(4) AUTHORISED REPRESENTATIVE SINCE 2009. BASED ON OUR INVESTIGATIONS, IT IS MOST LIKELY THAT THE DS WAS BARELY PASSING THE TRANSMISSION CHECK ENOUGH TO TREAT AND MAY POTENTIALLY HAVE BEEN CAUSING THE INJURIES. CONCLUSION: THIS DELIVERY SYSTEM IN ITS PRESENT STATE IS UNUSABLE DUE TO THE LOW TRANSMISSION. WHEN THE TRANSMISSION IS BELOW 70% THE LASER WILL NOT CALIBRATE AND CANNOT BE USED. OUR RECORDS INDICATE THAT THE DEVICE WAS SOLD WITH A DIFFERENT SERIAL NUMBER (B)(4) MANUFACTURED IN 2011. THE CUSTOMER RETURNED DS SERIAL NUMBER (B)(4) MANUFACTURED IN 2009. THIS DS WAS NOT PROVIDED TO THIS CUSTOMER BY (B)(4) BUT WAS SOLD BY (B)(4) TO A DIFFERENT CUSTOMER IN (B)(6) IN 2009. WE DO NOT HAVE ANY SERVICE RECORDS FOR THESE DELIVERY SYSTEMS PRIOR TO THIS REPORT.

    Description of Event or Problem · 1

    ON MARCH 8, 2017 ACCOUNT REPORTED THAT FIVE PATIENTS TREATED IN THE MONTH OF (B)(6) 2017 HAD RESPONDED WITH ADVERSE EVENTS. ALL THE PATIENTS WERE BEING TREATED FOR LASER HAIR REMOVAL AS INDICATED IN NOTES BELOW: PATIENT (B)(6) TREATED ON (B)(6) 2017 FOR UNWANTED HAIR GROWTH IN THE UNDERARMS, BIKINI (SIDES AND TOP) AND LOWER LEGS. THE POSTERIOR LOWER LEGS RESPONDED WITH BURNS AND ARCUATE SCABS WHICH HAD COMPLETELY RESOLVED AS OF (B)(6) 2017. PATIENT (B)(6) TREATED ON (B)(6) 2017 FOR UNWANTED HAIR GROWTH IN THE UNDERARMS AND LOWER LEGS. THE LOWER LEGS RESPONDED WITH BURNS AND AMBIGOUS PATTERN WITH HYPERPIGMENTATION. PATIENT (B)(6) TREATED ON (B)(6) 2017 FOR UNWANTED HAIR GROWTH ON THE CHIN AND RESPONDED WITH BURNS AND ARCUATE SCABS ON THE TREATED AREA. PATIENT (B)(6) TREATED ON (B)(6) 2017 FOR UNWANTED HAIR GROWTH IN THE AREOLA AND NAVAL AREA. THE TREATED AREAS RESPONDED WITH BURNS AND ARCUATE SCABS WITH NO PROLONGED PROBLEMS. THE ISSUE WAS RESOLVED AS OF (B)(6) 2017. PATIENT (B)(6) TREATED ON (B)(6) 2017 FOR UNWANTED HAIR GROWTH ON THE CHIN AND BIKINI SIDES, UPPER INNER THIGHS, LABIA MAJORA, MONS PUBIS AND RESPONDED WITH BURNS AND ARCUATE AREAS OF HYPERPIGMENTATION AND SCABS ON THE TREATED AREA. UPON INVESTIGATION, IT WAS ESTABLISHED THAT PATIENT (B)(6) TREATED ON (B)(6) 2017, WAS NOT TREATED FOLLOWING THE RECOMMENDED TREATMENT GUIDELINES. THE PATIENT WAS BURNED DUE TO EXCESS CRYOGEN BEING SPRAYED ON THE TREATMENT AREA. THIS WAS MOST LIKELY A USE ERROR BY THE TREATING PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255518 CANDELA GENTLEMAX LASER SYSTEM CANDELA GENTLEMAX SYSTEM GEX CANDELA CORPORATION 9914-00-0400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1