MAUDE Adverse Event Report: LUMENIS LTD. ACUPULSE 40 WATT; POWERED LASER SURGICAL INSTRUMENT

Model Number	ACUPULSE 40 WATT
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that during a procedure in which a lumenis acupulse 40w co2 laser system was being utilized, the aiming beam disappeared.Unable to proceed with the laser, the procedure was successfully completed with an alternate device.No report of injury was received, and the device malfunction did not cause or contribute to any change in the patient's condition.
Additional Manufacturer Narrative
A lumenis service engineer visited the site one (1) day after the reported event.Upon inspection, the engineer could not duplicate the reported "aiming beam settings would not respond even after restarting" and after performed safety checks and verifying the system is working within manufacturer specifications the system was returned to the facility safe and ready for use.The engineer looked at the error log and found nothing related to the aiming beam and/or software.Unrelated to the complaint the engineer found that the microswitch joystick connection is broken and will need to be replaced.The engineer ordered a new part and will return to replace it.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 22_mar-2017 and installed at the customers site on (b)(6) 2017.A review of system risk files (rd-1148040 rev t) revealed risk #1.35 " no (or low intensity) aiming beam " which have the potential to lead to tissue damage".And risk #10.1 " device malfunction" which have the potential to lead to adverse effects of alternative treatments".The risks likelihood has been quantified and found to be remote, and the risks has been characterized and documented as acceptable within full risk assessment.In this case, an alternate laser was brought in to complete the case with no complications to the patient.Although the alleged 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.The engineer could not duplicate the reported event and could find nothing visually wrong with the system, therefore, the cause of the event could not be established.Lumenis is closing this complaint but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (doc (b)(4)) and per post marketing surveillance procedure (doc (b)(4)).

• Brand Name: ACUPULSE 40 WATT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 12765795
• Report Number: 3004135191-2021-00072
• Device Sequence Number: 11800130
• Product Code: GEX
• UDI-Device Identifier: 07290109140315
• UDI-Public: 07290109140315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ACUPULSE 40 WATT
• Device Catalogue Number: GA-1000000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown