MAUDE Adverse Event Report: SCITON INC. JOULE WITH DIVA; POWERED LASER SURGICAL INSTRUMENT

Model Number	JOULE
Health Effect - Clinical Codes	Itching Sensation (1943); Urinary Tract Infection (2120); Discharge (2225); Dysuria (2684)
Date of Event	08/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(4) 2018, sciton was able to connect with the patient via telephone.The patient indicated that she was treated by a physician assistant at medical treatment office.Patient said she has atrophic vaginitis, "the laser did the job" and that the "tissue thickened as expected".The patient also indicated that the astrogen cream she has been taking is now not effective because of thicker tissue.She said "nothing was done incorrectly".She is cured of her uti and is planning to visit medical treatment office next week.On (b)(4) 2018, sciton called medical treatment office to learn more about this event.The receptionist at the medical treatment office said that the coordinator was in a meeting and will return the call as soon as she is free.The coordinator returned the call and informed sciton that she was not aware of any adverse event complaint from the patient.Upon her request, sciton forwarded to her fda's medwatch report mw5079671.The coordinator said she would contact sciton should that be necessary after the patient visits them.
Event or Problem Description
On (b)(6) 2018 i underwent 3rd treatment for laser vaginal therapy.The first two treatments were unremarkable.Several days following the 3rd treatment, i experienced some discharge, itching and dysuria.On (b)(6) went on a 7 day course of amox-clov 500mg-125 mg with no resolution.Visited family medicine on (b)(6) with continued complaint of dysuria.Wet prep revealed bacteria and went on a 7 day course of flagyl.Dysuria continued.(b)(6), said urologist, diagnosed with uti, and now on 7 day course of ceftin.Concomitant medical: synthroid, metformin, lisinopril, lipitor, nexium, yuvafem, baby aspirin, daily vitamin.

• Brand Name: JOULE WITH DIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): SCITON INC.; 925 commercial street; palo alto CA 94303
• MDR Report Key: 8071626
• Report Number: 2953696-2018-00023
• Device Sequence Number: 19255713
• Product Code: GEX
• UDI-Device Identifier: 00863249000305
• UDI-Public: 0863249000305
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: JOULE
• Device Catalogue Number: 1500-016-20
• Device Lot Number: 15716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention