MAUDE Adverse Event Report: LUMENIS LTD. ACUPULSE; LASER POWERED SURGICAL INSTRUMENT

Model Number	ACUPULSE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis contacted the facility several times to request patient treatment settings, patient information, and patient photographs, which the facility partially provided.The facility sent incident forms without photos.In addition, lumenis requested the information regarding the facility's sterilization methods and frequency of treatments with the acupulse 30w femtouch, which were received and are summarized below.The initial reporter informed lumenis of the event approximately 17 months after it was reported to have occurred.Nevertheless, through device records lumenis can establish the device maintenance in the time period before and after the reported adverse event.At the request of the original purchaser, (b)(4), the device was installed at a clinic operated by (b)(6) in (b)(6) on 07/12/2017.The adverse event with lc occurred on (b)(6) 2017 at a clinic operated by (b)(6) in (b)(6).In april 2018, after shoreline purchased the unit from (b)(4), lumenis performed warranty service on the unit in (b)(6) with respect to a scanner.Following the incident, no work order was opened because the event was not reported to lumenis until march 15, 2019, and no maintenance was requested by the facility.The facility reports that they performed no more than one treatment per day using the affected device, sterilized the device according to the user manual, and stopped working with the femtouch at an undetermined date.A lumenis health professional and clinical trainer reviewed the submitted materials and concluded that "patient was treated on (b)(6) 2017 for urinary incontinence with the acupulse femtouch handpiece.The patient states she woke up the following day with a green discharge, tenderness and throbbing pain.She was seen by a physician 10 days following the treatment and treated for a yeast infection.She was subsequently hospitalized for 5 days for sepsis.She has had several vaginal yeast infections and has been treated with diflucan.Treatment settings were stated as 10mj and 10% density 1 pass on deep settings with the acuscan 120 scanner handpiece.Clinician also states proper cleaning procedures were taken as per lumenis protocol.This is a user error.Lumenis protocol settings for vaginal treatments is the cw settings on the acupulse using the acuscan 120 scanner, not the deep (superpulse) as stated in the report.I reached out to (b)(6) the manager the week of march 11th.She returned my call on march 22nd and left a voice mail.When we finally spoke i asked her about the patient's vaginal health, pap, pelvic exam prior to treatment.And she stated that everything was fine." the lumenis health professional and clinical trainer determined the injury to be with 'moderate severity'.
Event or Problem Description
The vaginal treatment was for stress incontinence of the bladder with the femtouch sn (b)(4) and hp sn (b)(4).After having a vaginal discharge for some 10 days, patient was treated for yeast infection and felt fine for six weeks.Thereafter, the patient suffered renewed symptoms followed by a serious infection resulting in hospitalization for 5 days with sepsis.

• Brand Name: ACUPULSE
• Common Device Name: LASER POWERED SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ,; IS 20692,
• MDR Report Key: 8512500
• Report Number: 3004135191-2019-00045
• Device Sequence Number: 13933639
• Product Code: GEX
• UDI-Device Identifier: 07290109142128
• UDI-Public: 07290109142128
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/14/2019

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: ACUPULSE
• Device Catalogue Number: GA-0000070
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/13/2019
• 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: Other
• Patient Age: 42 YR