SPLENDOR X ALEX + ND:YAG
Report
- Report Number
- 1720381-2024-00003
- Event Type
- Injury
- Date Received
- August 23, 2024
- Date of Event
- August 4, 2024
- Report Date
- August 22, 2024
- Manufacturer
- BIOS S.R.L.
- Product Code
- GEX
- UDI-DI
- 08052049500067
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 117
Narratives
THE FOLLOWING INFORMATION COMES FROM THE MEDWATCH ISSUED BY LUMENIS WITH NUMBER 3020611964-2024-00003: LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN, PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTO. THE CUSTOMER REPORTED ON INJURY OF PATIENT'S SKIN FOLLOWING TREATMENT ON FACE AREA. THE DEVICE GA-5000000: (B)(6) WAS INSTALLED IN THE FACILITY ON 6/14/2024 AND IT'S ON WARRANTY. THERE IS NO ALLEGATION OF MALFUNCTION. REGIONAL CLINICAL EXPERT REVIEWED THE DATA AND ADVISED: "LUMENIS RECEIVED NOTIFICATION OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X USING THE ROSACEA PRESET SETTINGS AS FOLLOWS: 5MM SPOT SIZE, 25MS PD, FLUENCE NOT LISTED, HZ NOT LISTED, 4+ PASSES DONE, ZIMMER COOLING NOT USED FOR THE FIRST CHEEK. TEST PATCH WAS NOT PERFORMED, CONSENT WAS SIGNED AND THE PATIENT DENIED CONTRAINDICATIONS TO LASER TREATMENT. PHOTOS PROVIDED BY THE CUSTOMER SHOWS A FITZPATRICK III (POSSIBLY IV- HER ETHNICITY IS NOT LISTED) WITH MARKED EDEMA, ERYTHEMA, AND YELLOW, FLUID FILLED BULLAE OVER THE BILATERAL LOWER THIRD OF THE CHEEKS TO THE JAWLINE. THE PATIENT'S LEFT LOWER FACE IS MORE SEVERELY AFFECTED. POSSIBLE EFFECTS: PROLONGED DERMATOLOGICAL CARE WITH PRESCRIPTIVE ORAL AND TOPICAL MEDICATIONS, POSSIBLE RECONSTRUCTIVE PROCEDURES, POSSIBLE LONG TERM PIGMENTARY CHANGES. INVESTIGATION CONCLUSIONS: USER ERROR. THE ZIMMER CHILLER WAS NOT USED ON ONE SIDE OF THE FACE, A TEST PATCH AND PAUSE WERE NOT DONE PER IFU, TISSUE RESPONSE WAS NOT PROPERLY EVALUATED, AN INAPPROPRIATE NUMBER OF PASSES WERE USED OVER A LARGE SURFACE AREA OF THE FACE. THE SEVERITY IS 6-8 WITH SECOND-THIRD DEGREE BURNS IN A HIGH PROFILE AREA. IT IS POSSIBLE THAT THIS PATIENT WILL REQUIRE RECONSTRUCTIVE PROCEDURES AND MAY HAVE PERMANENT INJURY WITHOUT IMPAIRMENT." SINCE SEVERITY OF THE INJURY IS HIGH RATED 8 OUT OF 10, LUMENIS IS REPORTING THIS CASE THE FDA AS AN IMPORTER. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.
THE FOLLOWING INFORMATION COMES FROM THE MEDWATCH ISSUED BY LUMENIS WITH NUMBER 3020611964-2024-00003: LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. ATTEMPTS BY EMAILS AND PHONE CALLS HAVE BEEN MADE TO OBTAIN, PATIENT TREATMENT SETTINGS, PATIENT INFORMATION, PATIENT PHOTO. THE CUSTOMER REPORTED ON INJURY OF PATIENT'S SKIN FOLLOWING TREATMENT ON FACE AREA. THE DEVICE GA-5000000: (B)(6) WAS INSTALLED IN THE FACILITY ON 6/14/2024 AND IT'S ON WARRANTY. THERE IS NO ALLEGATION OF MALFUNCTION. REGIONAL CLINICAL EXPERT REVIEWED THE DATA AND ADVISED: "LUMENIS RECEIVED NOTIFICATION OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X USING THE ROSACEA PRESET SETTINGS AS FOLLOWS: 5MM SPOT SIZE, 25MS PD, FLUENCE NOT LISTED, HZ NOT LISTED, 4+ PASSES DONE, ZIMMER COOLING NOT USED FOR THE FIRST CHEEK. TEST PATCH WAS NOT PERFORMED, CONSENT WAS SIGNED AND THE PATIENT DENIED CONTRAINDICATIONS TO LASER TREATMENT. PHOTOS PROVIDED BY THE CUSTOMER SHOWS A FITZPATRICK III (POSSIBLY IV- HER ETHNICITY IS NOT LISTED) WITH MARKED EDEMA, ERYTHEMA, AND YELLOW, FLUID FILLED BULLAE OVER THE BILATERAL LOWER THIRD OF THE CHEEKS TO THE JAWLINE. THE PATIENT'S LEFT LOWER FACE IS MORE SEVERELY AFFECTED. POSSIBLE EFFECTS: PROLONGED DERMATOLOGICAL CARE WITH PRESCRIPTIVE ORAL AND TOPICAL MEDICATIONS, POSSIBLE RECONSTRUCTIVE PROCEDURES, POSSIBLE LONG TERM PIGMENTARY CHANGES. INVESTIGATION CONCLUSIONS: USER ERROR. THE ZIMMER CHILLER WAS NOT USED ON ONE SIDE OF THE FACE, A TEST PATCH AND PAUSE WERE NOT DONE PER IFU, TISSUE RESPONSE WAS NOT PROPERLY EVALUATED, AN INAPPROPRIATE NUMBER OF PASSES WERE USED OVER A LARGE SURFACE AREA OF THE FACE. THE SEVERITY IS 6-8 WITH SECOND-THIRD DEGREE BURNS IN A HIGH PROFILE AREA. IT IS POSSIBLE THAT THIS PATIENT WILL REQUIRE RECONSTRUCTIVE PROCEDURES AND MAY HAVE PERMANENT INJURY WITHOUT IMPAIRMENT." SINCE SEVERITY OF THE INJURY IS HIGH RATED 8 OUT OF 10, LUMENIS IS REPORTING THIS CASE THE FDA AS AN IMPORTER. SHOULD ADDITIONAL SIGNIFICANT INFORMATION BECOME AVAILABLE, THE COMPLAINT RECORD WILL BE UPDATED ACCORDINGLY AND A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.
ON AUGUST 9TH 2024 LUMENIS (MR. (B)(6) REPORTS (VERBATIM): "I'M INFORMING YOU THAT WE GOT A NEW SAFETY (B)(4). THE PATIENT REPORTED ON INJURY (BLISTERS AFTER TREATMENT) USING GA-5000000: (B)(6). THERE IS NO ALLEGATION ON MALFUNCTION. THE DEVICE IS ON WARRANTY. WE'RE WAITING FOR CLINICAL EVALUATION AND TESTING/SERVICE. CURRENTLY, OUR CLINICAL EXPERT IS IN TOUCH WITH THE CUSTOMER." INCIDENT FORM IS COMPILED, HANDWRITTEN AND PHOTOGRAPHED. PICTURES OF FORM ATTACHED TO THE COMPLAINT NOTIFICATION MAIL. THE FOLLOWING INFORMATION ARE RETRIEVED: TEST SPOT NOT DONE. TIP SIZE 5 MM, SQUARE, 25 MS PULSE. SMOKE EVACUATOR 5 OF 5, COOLING OFF FOR FIRST 4 PASSES. HAIR LIGHT BROWN AND FINE, NO PICTURE AVAILABLE. PATIENT: INITIALS C.S., NO SESSIONS BEFORE THIS, FEMALE, LIGHT SKIN. NO CONTRAINDICATIONS KNOWN. SEVERE EVENT. EVENT: BURN, BLISTERING, INTENSE/ABNORMAL PAIN. REQUIRED MEDICAL INTERVENTION: PATIENT WENT TO THEIR DERMATOLOGIST; PERMANENT EFFECTS NOT KNOWN. PROBLEM DESCRIPTION (AS REPORTED): "SEE E-MAIL FOR FULL DESCRIPTION. CLIENT BURNED BY LUMENIS TRAINER DURING ROSACEA TREATMENT. COOLING WAS NOT APPLIED TO FIRST FOUR PASSES" ON AUGUST 9TH, 2024 BIOS (MR. (B)(6) ASKED TO LUMENIS (MS. (B)(6): "THE ADOPTED TREATMENT IS NOT VERY CLEAR. MAY YOU FIND SOME MORE DETAILED INFORMATION? IT SEEMS THE PATIENT WAS INJURED BY A LUMENIS' PERSON. MAY YOU CONFIRM? MAY YOU INCLUDE THE PERSON'S QUALIFICATION FOR THE USE OF THE DEVICE ON PATIENTS? THE INCIDENT FORM REPORTS NO TEST SPOT WAS DONE. MAY YOU CONFIRM, AND WAS THERE ANY REASON FOR AVOIDING IT?" THE REPLY IS THE FOLLOWING ON AUGUST 11TH, 2024: "THE PRESET THAT WAS USED WAS "ROSACEA" UNDER THE LP YAG VASCULAR SUBSET. THIS IS NOT A PRESET THAT WE UTILIZE IN THE US. WE INSTRUCT THAT THE SKIN CONDITION ROSACEA IS BETTER ADDRESSED WITH IPL OR BBL. WE DO UTILIZE THE FACIAL TELANGIECTASIA PRESETS OFTEN FOR TREATING INDIVIDUAL VASCULAR LESIONS. THE TRAINER (WHO WAS A CONTRACT "PER DIEM" TRAINER- NOT A LUMENIS EMPLOYEE) STATES SHE WAS NOT PERFORMING THE TREATMENT AND STATES SHE HAS VIDEO. I BELIEVE THE FORM WHEN IT STATES NO TEST SPOT WAS DONE, AS THIS TRAINING WAS CONDENSED DUE TO TIME CONSTRAINTS AND THE PATIENT'S LIGHT FITZPATRICK TYPE. I HOPE THIS HELPS. I'LL HAVE THE COMPLAINT CLOSED OUT SOON, IT IS STRAIGHTFORWARD WITH AN INAPPROPRIATE NUMBER OF PASSES WITHOUT THE USE OF THE ZIMMER CHILLER AND WITHOUT PAUSING TO ASSESS TISSUE RESPONSE PRIOR TO CONTINUING. I AM DOING A SITE VISIT WITH THIS CUSTOMER AT THE END OF THIS WEEK, AND I WOULD ALSO LIKE TO GET AN UPDATE ON THE PATIENT'S CONDITION PRIOR TO ASSIGNING A SEVERITY." INVESTIGATION RESULTS: CLINICAL EVALUATION WAS COMPLETED BY LUMENIS ON AUGUST 15TH, 2024. IT REPORTS, VERBATIM (MS. (B)(6): "LUMENIS RECEIVED NOTIFICATION OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X USING THE ROSACEA PRESET SETTINGS AS FOLLOWS: 5MM SPOT SIZE, 25MS PD, FLUENCE NOT LISTED, HZ NOT LISTED, 4+ PASSES DONE, ZIMMER COOLING NOT USED FOR THE FIRST CHEEK. TEST PATCH WAS NOT PERFORMED, CONSENT WAS SIGNED AND THE PATIENT DENIED CONTRAINDICATIONS TO LASER TREATMENT. PHOTOS PROVIDED BY THE CUSTOMER SHOWS A FITZPATRICK III (POSSIBLY IV- HER ETHNICITY IS NOT LISTED) WITH MARKED EDEMA, ERYTHEMA, AND YELLOW, FLUID FILLED BULLAE OVER THE BILATERAL LOWER THIRD OF THE CHEEKS TO THE JAWLINE. THE PATIENT'S LEFT LOWER FACE IS MORE SEVERELY AFFECTED. THIS PATTERN CONFIRMS THE TRAINER'S NARRATIVE. AS OF THE DATE OF REPORTING, THE PATIENT WAS ACTIVELY RECEIVING MEDICAL CARE AND HAD CONTACTED HER DERMATOLOGIST WHEN SHE SAW BLISTERS FORM. HER DERMATOLOGIST PRESCRIBED WOUND CARE, NSAIDS, AND ORAL ANTIBIOTICS. I ADVISED THE CUSTOMER TO RELAY TO THE PATIENT THAT SHE SHOULD CONTINUE CARE WITH HER DERMATOLOGIST AND THAT SHE BE SEEN IN PERSON FREQUENTLY BY BOTH THE CUSTOMER AND HER DERMATOLOGIST (I WAS UNSURE IF THE INITIAL DERM APPT WAS VIRTUAL OR IN PERSON). THIS EVENT OCCURRED DURING A LUMENIS CERTIFIED CLINICAL TRAINING. THE TRAINER NOTIFIED ME (HER SUPERVISOR) THE DAY PRIOR (8/4/24) TO THE EVENT BEING OFFICIALLY REPORTED. THE TRAINER DID NOT INCLUDE PHOTOS. HER NARRATIVE AGREES WITH THE CUSTOMER'S RECOLLECTION OF EVENTS ALTHOUGH THE TRAINER STATES THAT SHE WAS NOT PERFORMING THE TREATMENT. THE NURSE PRACTITIONERS ATTENDING TRAINING WERE THE TREATMENT PROVIDERS. THIS IS CLEAR USER ERROR. THE SEVERITY IS 6-8 WITH SECOND-THIRD DEGREE BURNS IN A HIGH PROFILE AREA. IT IS POSSIBLE THAT THIS PATIENT WILL REQUIRE RECONSTRUCTIVE PROCEDURES AND MAY HAVE PERMANENT INJURY WITHOUT IMPAIRMENT. ROOT CAUSE FAILURE: USER ERROR. THE ZIMMER CHILLER WAS NOT USED ON ONE SIDE OF THE FACE, A TEST PATCH AND PAUSE WERE NOT DONE PER IFU, TISSUE RESPONSE WAS NOT PROPERLY EVALUATED, AN INAPPROPRIATE NUMBER OF PASSES WERE USED OVER A LARGE SURFACE AREA OF THE FACE. ROOT CAUSE: USER ERROR POSSIBLE EFFECTS: PROLONGED DERMATOLOGICAL CARE WITH PRESCRIPTIVE ORAL AND TOPICAL MEDICATIONS, POSSIBLE RECONSTRUCTIVE PROCEDURES, POSSIBLE LONG TERM PIGMENTARY CHANGES. USER ERROR. THE ZIMMER CHILLER WAS NOT USED ON ONE SIDE OF THE FACE, A TEST PATCH AND PAUSE WERE NOT DONE PER IFU, TISSUE RESPONSE WAS NOT PROPERLY EVALUATED, AN INAPPROPRIATE NUMBER OF PASSES WERE USED OVER A LARGE SURFACE AREA OF THE FACE."
ON AUGUST 9TH 2024 LUMENIS (MR.(B)(6) ) REPORTS (VERBATIM): "I'M INFORMING YOU THAT WE GOT A NEW SAFETY (B)(4). THE PATIENT REPORTED ON INJURY (BLISTERS AFTER TREATMENT) USING GA-5000000:(B)(6). THERE IS NO ALLEGATION ON MALFUNCTION. THE DEVICE IS ON WARRANTY. WE'RE WAITING FOR CLINICAL EVALUATION AND TESTING/SERVICE. CURRENTLY, OUR CLINICAL EXPERT IS IN TOUCH WITH THE CUSTOMER." INCIDENT FORM IS COMPILED, HANDWRITTEN AND PHOTOGRAPHED. PICTURES OF FORM ATTACHED TO THE COMPLAINT NOTIFICATION MAIL. THE FOLLOWING INFORMATION ARE RETRIEVED: TEST SPOT NOT DONE. TIP SIZE 5 MM, SQUARE, 25 MS PULSE. SMOKE EVACUATOR 5 OF 5, COOLING OFF FOR FIRST 4 PASSES. HAIR LIGHT BROWN AND FINE, NO PICTURE AVAILABLE. PATIENT: INITIALS (B)(6), NO SESSIONS BEFORE THIS, FEMALE, LIGHT SKIN. NO CONTRAINDICATIONS KNOWN. SEVERE EVENT. EVENT: BURN, BLISTERING, INTENSE/ABNORMAL PAIN. REQUIRED MEDICAL INTERVENTION: PATIENT WENT TO THEIR DERMATOLOGIST; PERMANENT EFFECTS NOT KNOWN. PROBLEM DESCRIPTION (AS REPORTED): "SEE E-MAIL FOR FULL DESCRIPTION. CLIENT BURNED BY LUMENIS TRAINER DURING ROSACEA TREATMENT. COOLING WAS NOT APPLIED TO FIRST FOUR PASSES" ON (B)(6) 2024 BIOS (MR. (B)(6)) ASKED TO LUMENIS (MS. (B)(6)): "THE ADOPTED TREATMENT IS NOT VERY CLEAR. MAY YOU FIND SOME MORE DETAILED INFORMATION? IT SEEMS THE PATIENT WAS INJURED BY A LUMENIS' PERSON. MAY YOU CONFIRM? MAY YOU INCLUDE THE PERSON'S QUALIFICATION FOR THE USE OF THE DEVICE ON PATIENTS? THE INCIDENT FORM REPORTS NO TEST SPOT WAS DONE. MAY YOU CONFIRM, AND WAS THERE ANY REASON FOR AVOIDING IT?" THE REPLY IS THE FOLLOWING ON AUGUST 11TH, 2024: "THE PRESET THAT WAS USED WAS "ROSACEA" UNDER THE LP YAG VASCULAR SUBSET. THIS IS NOT A PRESET THAT WE UTILIZE IN THE US. WE INSTRUCT THAT THE SKIN CONDITION ROSACEA IS BETTER ADDRESSED WITH IPL OR BBL. WE DO UTILIZE THE FACIAL TELANGIECTASIA PRESETS OFTEN FOR TREATING INDIVIDUAL VASCULAR LESIONS. THE TRAINER (WHO WAS A CONTRACT "PER DIEM" TRAINER- NOT A LUMENIS EMPLOYEE) STATES SHE WAS NOT PERFORMING THE TREATMENT AND STATES SHE HAS VIDEO. I BELIEVE THE FORM WHEN IT STATES NO TEST SPOT WAS DONE, AS THIS TRAINING WAS CONDENSED DUE TO TIME CONSTRAINTS AND THE PATIENT'S LIGHT FITZPATRICK TYPE. I HOPE THIS HELPS. I'LL HAVE THE COMPLAINT CLOSED OUT SOON, IT IS STRAIGHTFORWARD WITH AN INAPPROPRIATE NUMBER OF PASSES WITHOUT THE USE OF THE ZIMMER CHILLER AND WITHOUT PAUSING TO ASSESS TISSUE RESPONSE PRIOR TO CONTINUING. I AM DOING A SITE VISIT WITH THIS CUSTOMER AT THE END OF THIS WEEK, AND I WOULD ALSO LIKE TO GET AN UPDATE ON THE PATIENT'S CONDITION PRIOR TO ASSIGNING A SEVERITY." INVESTIGATION RESULTS: CLINICAL EVALUATION WAS COMPLETED BY LUMENIS ON (B)(6) 2024. IT REPORTS, VERBATIM (MS. (B)(6)): "LUMENIS RECEIVED NOTIFICATION OF AN ADVERSE EVENT INVOLVING THE SPLENDOR X USING THE ROSACEA PRESET SETTINGS AS FOLLOWS: 5MM SPOT SIZE, 25MS PD, FLUENCE NOT LISTED, HZ NOT LISTED, 4+ PASSES DONE, ZIMMER COOLING NOT USED FOR THE FIRST CHEEK. TEST PATCH WAS NOT PERFORMED, CONSENT WAS SIGNED AND THE PATIENT DENIED CONTRAINDICATIONS TO LASER TREATMENT. PHOTOS PROVIDED BY THE CUSTOMER SHOWS A FITZPATRICK III (POSSIBLY IV- HER ETHNICITY IS NOT LISTED) WITH MARKED EDEMA, ERYTHEMA, AND YELLOW, FLUID FILLED BULLAE OVER THE BILATERAL LOWER THIRD OF THE CHEEKS TO THE JAWLINE. THE PATIENT'S LEFT LOWER FACE IS MORE SEVERELY AFFECTED. THIS PATTERN CONFIRMS THE TRAINER'S NARRATIVE. AS OF THE DATE OF REPORTING, THE PATIENT WAS ACTIVELY RECEIVING MEDICAL CARE AND HAD CONTACTED HER DERMATOLOGIST WHEN SHE SAW BLISTERS FORM. HER DERMATOLOGIST PRESCRIBED WOUND CARE, NSAIDS, AND ORAL ANTIBIOTICS. I ADVISED THE CUSTOMER TO RELAY TO THE PATIENT THAT SHE SHOULD CONTINUE CARE WITH HER DERMATOLOGIST AND THAT SHE BE SEEN IN PERSON FREQUENTLY BY BOTH THE CUSTOMER AND HER DERMATOLOGIST (I WAS UNSURE IF THE INITIAL DERM APPT WAS VIRTUAL OR IN PERSON). THIS EVENT OCCURRED DURING A LUMENIS CERTIFIED CLINICAL TRAINING. THE TRAINER NOTIFIED ME (HER SUPERVISOR) THE DAY PRIOR (8/4/24) TO THE EVENT BEING OFFICIALLY REPORTED. THE TRAINER DID NOT INCLUDE PHOTOS. HER NARRATIVE AGREES WITH THE CUSTOMER'S RECOLLECTION OF EVENTS ALTHOUGH THE TRAINER STATES THAT SHE WAS NOT PERFORMING THE TREATMENT. THE NURSE PRACTITIONERS ATTENDING TRAINING WERE THE TREATMENT PROVIDERS. THIS IS CLEAR USER ERROR. THE SEVERITY IS 6-8 WITH SECOND-THIRD DEGREE BURNS IN A HIGH PROFILE AREA. IT IS POSSIBLE THAT THIS PATIENT WILL REQUIRE RECONSTRUCTIVE PROCEDURES AND MAY HAVE PERMANENT INJURY WITHOUT IMPAIRMENT. ROOT CAUSE FAILURE: USER ERROR. THE ZIMMER CHILLER WAS NOT USED ON ONE SIDE OF THE FACE, A TEST PATCH AND PAUSE WERE NOT DONE PER IFU, TISSUE RESPONSE WAS NOT PROPERLY EVALUATED, AN INAPPROPRIATE NUMBER OF PASSES WERE USED OVER A LARGE SURFACE AREA OF THE FACE. ROOT CAUSE: USER ERROR POSSIBLE EFFECTS: PROLONGED DERMATOLOGICAL CARE WITH PRESCRIPTIVE ORAL AND TOPICAL MEDICATIONS, POSSIBLE RECONSTRUCTIVE PROCEDURES, POSSIBLE LONG TERM PIGMENTARY CHANGES. USER ERROR. THE ZIMMER CHILLER WAS NOT USED ON ONE SIDE OF THE FACE, A TEST PATCH AND PAUSE WERE NOT DONE PER IFU, TISSUE RESPONSE WAS NOT PROPERLY EVALUATED, AN INAPPROPRIATE NUMBER OF PASSES WERE USED OVER A LARGE SURFACE AREA OF THE FACE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1256997 | SPLENDOR X ALEX + ND:YAG | FAMILY OF SQUARE EPIL | GEX | BIOS S.R.L. | 08052049500067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |