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U.S. Department of Health and Human Services

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

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LUMENIS LTD. FEMTOUCH¿ LASER VAGINAL HANDPIECE Back to Search Results
Model Number FEMTOUCH¿ HANDPIECE
Device Problems Device Reprocessing Problem; Handpiece
Event Date 08/01/2016
Event Type  Malfunction  
Manufacturer Narrative

Review of femtouch serial no #(b)(4) dhr records showed it was manufactured according to relevant procedures, tested before release, and shipped according to specifications nevertheless, lumenis initiated a re-verification of the cleaning protocol on 08/18/2016. Femtouch #28 was returned for engineering and qa analysis on 08/29/2016: visual inspection confirmed the hand piece seemed to be clean and intact. The hand piece was disassembled for visual inspection of the inner part of the tip. Visual inspection of the inner part of the tip revealed dirty residues especially in the ventilation channels. The surface quality on the inner part was damaged and a color change was observed. Based on the amount of remaining debris inside the tip, lumenis concluded that most likely the tip was not cleaned and disinfected within 0. 5 hour after its use as required in the operator's manual. Further information received from customer showed that the femtouch was cleaned with an alkaline detergent (clinidet) instead of enzymatic detergent as instructed in the femtouch operator's manual (um-10065340en rev. B). Based on the above, lumenis preliminary conclusion was that customer failed to follow manufacturer cleaning instructions according to femtouch operator's manual (um-10065340 rev. B). Therefore, initial mdr analysis indicated that this event was deemed to not be reportable. However, receipt of re-validation test results of the cleaning instructions on 9/05/2016 showed the current protocol as stated in the instructions for use (ifu) were not effective for an assembled handpiece. This new information triggered re-evaluation of the event for reportability. Based on lumenis' re-evaluation of the event, the company determined that this event was likely reportable. Thus, out of an abundance of caution, the company is reporting this event as a 30 day mdr based on the receipt of new information on 9/5/2016. Lumenis initiated a capa (b)(4) for corrective action.

 
Event Description

On (b)(6) 2016, patient received femtouch treatment for vaginal atrophy associated with previous cervical cancer (19 years prior). The patient's post hysterectomy vaginal cavity was shorter than average, and stenosis was significant. Patient's vaginal health index score rated at 6/20 (ph was not tested) which was within the eligibility criteria for the femtouch treatment. Insertion of the probe upon commencement of treatment caused damage to the existing adhesions and scar tissue within the vaginal epithelium, and resulted in subsequent bleeding. Patient experienced pain but requested that the treatment to continue until it was finished. Following the procedure. The femtouch probe was immediately put into a container full of water to soak. On that day and multiple times over the following 3 days, the clinic staff tried to soak, scrub and drain the probe with both water and cyclohexane solution to remove the blood, but every time they stood it up to drip dry, it leaked a ring of blood around its base. No actual injury or harm was associated to this event. Based on additional correspondence with the customer, lumenis learned that the customer did not follow the cleaning protocol and also used an alkaline detergent (clinidet) instead of enzymatic detergent as instructed in the femtouch operator's manual (um-10065340en rev. B).

 
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Brand NameFEMTOUCH¿
Type of DeviceLASER VAGINAL HANDPIECE
Manufacturer (Section D)
LUMENIS LTD.
6 hakidma street
yokneam industrial park
yokneam 2069204, israel P.O.B . 24
IS  P.O.B. 240
Manufacturer (Section G)
LUMENIS LTD.
hakidma 6
yokneam industrial park
yokneam 2069204, israel P.O.B .240
IS  P.O.B.240
Manufacturer Contact
rafi barel
hakidma 6
yokneam industrial park
yokneam 2069204, israel  P.O.B-.240
  P.O.B.240
49599000
MDR Report Key5996716
Report Number3004135191-2016-00033
Device Sequence Number1
Product CodeGEX
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 10/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/04/2016
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberFEMTOUCH¿ HANDPIECE
Device Catalogue NumberAC-1007415
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/29/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/29/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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