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 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

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 19-sep-2019 and installed at the customers site on (b)(6) 2020.A lumenis service engineer visited the site one day after the reported event and examined the laser system.The engineer found first 45 mirror and first relay mirror for brick two damaged and replaced both mirrors.In addition, replaced the footswitch however, the it is not related to the original complaint.Performed optical bench alignment and centration all passed.Performed energy check and after verifying that the system is working within manufacturer specifications the system was returned to the facility safe and ready for use.A review of system risk files (b)(4) system failure" which has the potential to lead to prolonged procedure -or- ineffective treatment which may require re-operation.The risk likelihood has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within a full risk assessment.A two year historical review of similar complaints revealed that the same malfunctions of pulse 120 laser systems mirror failure has not led to serious injury in the past.To date lumenis is unaware of such events ever having led to injury.In this case, the patient was awakened from anesthesia and the procedure was subsequently cancelled.Although there was no report of injury associated with this event, lumenis believes that subjecting a patient to another round of anesthesia carries inherent risks, and in an abundance of caution, lumenis is reporting this event.Unrelated to the event, lumenis has initiated capa # (b)(4) to further investigate various optical issues with the holmium product family lasers.This complaint is being closed to capa (b)(4), and therefore follow-up mdr is not required.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 ureteroscopy procedure in which a lumenis pulse 120h laser was being utilized, the system stopped working.The procedure was subsequently cancelled and the patient was awakened from anesthesia.No injuries to patient and no report that the 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
• MDR Report Key: 11207130
• MDR Text Key: 280446966
• Report Number: 3004135191-2021-00003
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (y/n): N
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• 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-2009996
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1