MAUDE Adverse Event Report: LUMENIS, LTD. FEMTOUCH; LASER VAGINAL HANDPIECE

Model Number ACUPULSE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Blurred Vision (2137); Burning Sensation (2146)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly to obtain treatment and rn information, which was provided.An examination of the subject device by a lumenis technical expert concluded that after verifying all system functions including calibration and energy output verification, the subject device operated well within manufacture specifications.No device malfunction was reported or observed.A lumenis clinical director is currently reviewing the reported event details and patient treatment settings to determine the appropriateness of treatment.Based on the information that is currently available, a probable root cause cannot be determined at this time.Lumenis is continuing its investigation and will file a follow up mdr when additional information becomes available.

Event Description

A user facility rn reported on (b)(6) 2017 that after administering a femtouch treatment to a patient with a lumenis acupulse laser, the rn complained that her vision was blurred, felt pain and burning on the entire face, and irritation in both eyes.It was further reported that the rn visited an optometrist on (b)(6) 2017 who diagnosed the rn with a bacterial infection in both eyes.The rn further reported that eye protection was worn while administering the femtouch treatment.

• Brand Name: FEMTOUCH
• Type of Device: LASER VAGINAL HANDPIECE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma street; po box 240; yokneam industrial park, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS, LTD.; 6 hakidma street; po box 240; yokneam industrial park, 20692 ; IS 20692
• Manufacturer Contact: brett godfrey ; 1870 south milestone drive; salt lake city, UT 84104 ; 8016562663
• MDR Report Key: 6773154
• MDR Text Key: 82011957
• Report Number: 3004135191-2017-00107
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/08/2017

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
• Device Operator: Nurse
• Device Model Number: ACUPULSE
• Device Catalogue Number: GA-0000070
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR