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

Model Number	ACUPULSE 40 WATT
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional 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.The system was manufactured on 25-sep-2016 and installed at the customer's site on (b)(6) 2017.The user facility does not have a lumenis service contract, and it is unknown if the system had a pm service by a 3rd party and whether that might be the cause of this low coolant level.A lumenis service engineer visited the site six (6) days after the reported event and examined the laser system.The engineer inspected internal components, the fluorinert was low, and there was air in coolant lines.Inspected for leaks and found none, refilled system with flourinert.The engineer performed pm as per service manual, tested for power output, alignment, and functionality.The device was found to have met lumenis specifications and ready for use.A review of system risk files (rd-1148040 rev l) revealed risk #38; " device malfunction" which have the potential to lead to adverse effects of alternative treatments".The risk has been quantified and found to be remote, and the risk has been characterized and documented as acceptable within full risk assessment.In this case, the procedure was successfully completed manually, 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 an alternate method as intervention to prevent serious injury.In an abundance of caution, lumenis is reporting this malfunction.(b)(6) expert indicated that low coolant level for a 3 year-old system is not a common issue with this system, particularly if no proper preventive maintenance has been done.Lumenis is closing this complaint, but will continue to monitor this failure mode; complaint trending will continue to monitor per global complaint handling sop (b)(4) and per post marketing surveillance procedure (b)(4).
Event or Problem Description
A user facility reported that prior to beginning a procedure in which a lumenis acupulse 40w co2 laser system was to be utilized, the laser would not start up and presented error 12 (cooling system flow switch error) on its display.Unable to proceed with the laser, the procedure was successfully completed manually.No report of injury was received, and the device malfunction did not cause or contribute to any change in the patient's condition.

• Brand Name: ACUPULSE 40 WATT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT, PRODUCT CODE:
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9517620
• Report Number: 3004135191-2019-00150
• Device Sequence Number: 3244261
• Product Code: GEX
• UDI-Device Identifier: 07290109140315
• UDI-Public: 7290109140315
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100415
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/25/2019

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: 12/13/2019
• Initial Report FDA Received Date: 12/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1