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 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

Lumenis investigated the reported event by contacting the user facility directly for additional information.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 on 6-aug-2018, and installed at the customers site on 21-dec-2018.A lumenis service engineer visited the site two (2) days after the reported event and examined the laser system.The engineer discovered coolant well below the minimum fill level.Filled coolant then observed blast shield pitted in several locations, so replaced with one from customer's stock.The engineer continued testing and found an srm mirrors on brick#1 and brick#4 damaged.The damage may cause the system to go into case saver mode.Case saver mode is a system state that enables the user to continue using the system safely, however, with reduced power capability therefor, it is not related to the complaint, "shut down during a procedure." the engineer replaced the mirrors, and then observed main fiber port micro switch set at incorrect offset, so aligned micro switch to be flush with lens cell face.Performed inked fiber, and centration tests, requiring significant frm alignment.Performed safety checks; updated the software 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 (rd-1124690_ae) revealed risk #2.4.2 "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/ coolant well below the minimum 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, it was reported that the laser stopped during a procedure.No report of injury was received, and the device malfunction did not cause, or contribute to any change in the patient's condition.Although the device malfunction did not cause, or contribute to any change in the patient's condition.In an abundance of caution, lumenis is reporting this malfunction.According to lumenis service engineer it is most likely that what caused the incident was either the defects in brick#1 and brick#4 srm mirror as well as the misaligned microswitches on the fiber port.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 urology 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: 10734045
• MDR Text Key: 213022373
• Report Number: 3004135191-2020-00075
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (y/n): N
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2018
• 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