MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 120H; HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE

Model Number LUMENIS PULSE 120H

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly for additional information.Despite reasonable attempts, five (5) by phone and mail, no additional information had been provided.A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.Device was manufactured 16-may-2017 and installed at the customers 01-jan-2019.A lumenis service engineer visited the site one(1) day after the reported event and identified the fault to be with attenuator not working, he replaced the faulty attenuator control board.Filled system with coolant.Verified cooling system operation.Inspected system optics.Found two damaged blast shields.Replaced blast shields.Cleaned system optics.Verified system far and near optical alignments.Verified system output power.Completed operational and safety checks.Completed pm activities.System meets lumenis specification and is ready for use.A review of historical product complaints shows that the same malfunction of attenuator failure has not led to serious injury in the past two years.By design, the shutter position sensors are checked in standby and ready before the foots-witch is depressed.If both sensors are blocked or unblocked, the error will appear and the laser will disable lasing until the error is corrected.A review of system risk files (1124690 rev af) revealed risk #2.4.2; system failure which have the potential to lead to ineffective treatment which may require prolonged procedure -or- re-operation.The risk likelihood has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within full risk assessment.Although the device malfunction did not cause or contribute to any change in the patient's condition, it is uncertain if the user facility had to use the alternate device as intervention to prevent permanent damage.In an abundance of caution, lumenis is reporting this malfunction; according to the gso expert based on the age of the system, wear could have likely played a role in the misalignment failure.Therefore, no additional corrective or preventive action is determined necessary.Lumenis will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).

Event Description

A user facility reported that during a procedure in which a lumenis pulse 120h laser was being utilized, the system stopped working.Unable to continue with the system an alternate device was brought in to complete the procedure.No report of patient complications was received, and no report was received alleging the device malfunction caused or contributed to any change in the patient's condition.

• Brand Name: LUMENIS PULSE 120H
• Type of Device: HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 11241772
• MDR Text Key: 245786814
• Report Number: 3004135191-2021-00005
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LUMENIS PULSE 120H
• Device Catalogue Number: GA-0006801
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2017
• 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