MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE POWERSUITE 100W; HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES

Model Number	VERSAPULSE POWERSUITE 100W
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lumenis service engineer visited the site two (2) days after the reported event and examined the device.Upon arrival, found f6 on simmer board and f5 on hvps motherboard blown.Replaced both fuses and tested system.At start-up, f6 blew again.Replaced f6 again, switched white wires for brick 1 & 2, retested system.F6 and f5 blew again.The engineer ordered replacement parts and will return to replace parts and complete inspection of laser performance.The engineer returned, replaced simmer board and after performing operational and safety tests, the system was determined to have met lumenis specifications.The system was returned to the facility safe and ready for use.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 22-mar-2012 and installed at the customers site on 21-jun-2012.A review of system risk files found the risk of system failure (1007143_b - risk # 2.13) which has the potential to lead to ineffective treatment which may require prolonged operation 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.A review of historical product complaints from the past two years shows that the same malfunction of simmer board failures has not led to serious injury.According to the gso expert based on the age of the system, wear could have likely played a role in the failure.Therefore, no additional corrective or preventive action is determined necessary.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 no.(b)(4)) and per post marketing surveillance procedure (doc no.(b)(4)).
Event or Problem Description
A user facility reported that during a procedure in which a lumenis versapulse powersuite 100w laser was being utilized, the system displayed a message "all laser malfunction" and the laser remained inoperable.Unable to continue with the device, the facility brought in an alternate laser to complete the procedure.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: VERSAPULSE POWERSUITE 100W
• Common Device Name: HOLMIUM SURGICAL LASERS AND DELIVERY DEVICES AND ACCESSORIES
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 10355368
• Report Number: 3004135191-2020-00054
• Device Sequence Number: 19623687
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: 07290109140551
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• 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): 08/03/2020

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: VERSAPULSE POWERSUITE 100W
• Device Catalogue Number: 0638-803-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1