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

Model Number FEMTOUCH¿ HANDPIECE

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

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).

• Brand Name: FEMTOUCH
• Type of Device: LASER 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 ; IS P.O.B.240 ; 49599000
• MDR Report Key: 5996716
• MDR Text Key: 56382902
• Report Number: 3004135191-2016-00033
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100415
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: FEMTOUCH¿ HANDPIECE
• Device Catalogue Number: AC-1007415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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 Age: 52 YR
• Patient Weight: 60