• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LUMENIS, LTD. FEMTOUCH LASER VAGINAL HANDPIECE Back to Search Results
Model Number ACUPULSE
Device Problem Adverse Event Without Identified Device or Use Problem
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMTOUCH
Type of DeviceLASER 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 Key6773154
Report Number3004135191-2017-00107
Device Sequence Number1
Product CodeGEX
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
Date FDA Received08/08/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberACUPULSE
Device Catalogue NumberGA-0000070
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/02/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/08/2017 Patient Sequence Number: 1
-
-