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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEKA/ EL. EN. ELECTRONIC ENGINEERING SPA SMARTXIDE2 CO2 LASER FOR MONA LISA TOUCH TREATMENTS POWERED LASER SURGICAL INSTRUMENT

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DEKA/ EL. EN. ELECTRONIC ENGINEERING SPA SMARTXIDE2 CO2 LASER FOR MONA LISA TOUCH TREATMENTS POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Event Date 02/05/2016
Event Type  Injury  
Event Description

Vaginal scarring resulting in vaginal/rectal pain, spasms, and urinary urgency and frequency (interestitial cystitis - pelvic floor dysfunction). I was diagnosed with post-menopausal atrophic vaginitis and dyspareunia on (b)(6) 2016 by dr (b)(6). My symptoms were vaginal dryness, painful splitting of the tissue in the vaginal area which resulted in burning during urination, and occasional (maybe once a month) urinary incontinence. Several medications were tried, but were unsuccessful. Per her recommendation, i received the mona lisa touch (mlt) laser treatments on (b)(6) 2016 (consent form dated (b)(6) 2016; descriptive letter dated (b)(6) 2016). During 1st treatment, i experienced extreme pain when the probe was inserted into the vagina and when the probe was rotated. I heard a snapping sound and felt a strong, static-like sensation. I said, ¿ouch!¿ several times and told her it hurt. She said it was due to the severe dryness. She said she could not add any lubrication because it would affect the laser treatment. Still hopeful of improved health, i agreed to continue the treatment. She indicated that the pain was temporary. Thus, i completed the 3rd treatment on (b)(6) 2016. I returned to dr. (b)(6) on (b)(6) 2016 complaining of increased vaginal discomfort. She said it may be due to vaginal prolapse and suggested surgery or vaginal ring. I felt something else was occurring. A vaginal ultrasound was performed (ordered by dr (b)(6) on (b)(6) 2016). Results were normal. Mo mass was found. She assured me that my problems were not caused by the mona lisa touch treatments. Because i continued to have pain and several additional complications, i met with my primary care physician, dr (b)(6) on (b)(6) 2016. I reported pain/pressure on the left side of the pelvic region. It felt like something inside was putting pressure on the bladder. Sometimes i felt so much pressure/pain when i tried to sit down that i had to tighten my buttock muscles and tuck my right buttocks inward prior to slowly sitting down in order to minimize the pain. I also reported needing to urinate very frequently (every 15-30 minutes); could not hold much urine (about 2 ounces) without feeling pressure/pain. Any constipation, walking, or constricting of the pelvic muscles to hold urine cause more pain. Sometimes if i held my urine too long, it was difficult to urinate and caused significant pain to relax the muscles enough to urinate. He ordered a ct scan (performed on (b)(6) 2016; normal results) and recommended seeing a gastroenterologist and a urologist. The gastroenterologist dr (b)(6) conducted a colonoscopy of (b)(6) 2016. Results were normal except for mild hemorrhoids. I was diagnosed dr (b)(6), a urologist on (b)(6) 2016 with pelvic floor dysfunction. A cystoscopy was scheduled (results of the cystoscopy and urinalysis performed on (b)(6) 2016 are included ¿ results were normal (with slightly narrowing of the urethra); urinalysis was normal. He also prescribed physical therapy for pelvic floor dysfunction (see prescription for therapy dated (b)(6) 2016). I competed weekly sessions from (b)(6) 2016 through (b)(6) 2017 with little improvement. (b)(6) said i had scarring in the vaginal area that is not consistent with scarring from my hysterectomy (around 1985). She said the scarring was probably associated with burning from the laser (mlt). An mri was performed (ordered by dr (b)(6)) on (b)(6) 2017; noted was l4-5, l5-s1 degenerative disc disease with no acute bony abnormality. I have seen several more specialists and had more tests. The most recent diagnosis is interstitial cystitis (ic) (a form of pelvic floor dysfunction) by dr (b)(6), a urologist. Her testing included a ct ((b)(6) 2019), a cystoscopy ((b)(6) 2019), and a urinalysis ((b)(6) 2019). The pain has increased over the last couple of years; both in duration and intensity and now includes the rectal area as well as vaginal area. Some days, the pain/pressure/cramping is so severe that i cannot perform normal activities such as walking around the block. Currently, just to control the pain, spasms, urinary urgency and frequency associated with this condition, i take nortiptyline (10mg/day), mirabegron (25mg/day), gabapentin (400mg/day) and elmiron (100mg 3 times/day). In addition, i have modified my diet per the recommendations of the (b)(6) to eliminate all caffeine, tea, chocolate, acidic foods such as tomatoes, citrus, carbonated beverages, spices, and artificial sweeteners and all dairy products. I also have acupuncture every 2 weeks and see a personal counselor every 2 weeks to reduce stress. Since having the mona lisa touch treatment, the quality of my life has decreased significantly. I can no longer travel without considering the need for a bathroom. I am often tried due to the frequent night time bathroom visits (4-8 times) and the daily almost constant anxiety associated with my condition.

 
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Brand NameSMARTXIDE2 CO2 LASER FOR MONA LISA TOUCH TREATMENTS
Type of DevicePOWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
DEKA/ EL. EN. ELECTRONIC ENGINEERING SPA
MDR Report Key8470512
Report NumberMW5085417
Device Sequence Number1
Product CodeGEX
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 03/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/29/2019 Patient Sequence Number: 1
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