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

Model Number	ACUPULSE 40 WATT
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
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 20-sep-2015 and installed at the customer's site on 20-sep-2015.A review of system risk files ((b)(4)) revealed risk #(b)(4); " 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 completed with the same device with no complications to the patient.Though the procedure was successfully completed with the same device, it is uncertain if the user facility had to use the spare part as intervention to prevent permanent damage.In an abundance of caution lumenis is reporting this malfunction.The investigation for this and similar event is being handled under (b)(4) (from complaint (b)(4)).A preliminary investigation has found that a probable root cause is that the user twisted the cable rather than pulling it when removing the cable from the scanner head.Investigation is still ongoing, and if there will be a significant change, then lumenis will file a follow-up mdr.Lumenis 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 during a procedure in which a lumenis acupulse 40w laser was being utilized, the display presented error 69 - scanner position error, and the laser could no longer be used.They replaced the scanner cable with a spare they had in stock and after a 10 minutes delay were able to continue with the procedure using the same device.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: 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
• MDR Report Key: 9160275
• Report Number: 3004135191-2019-00115
• Device Sequence Number: 2332865
• Product Code: GEX
• UDI-Device Identifier: 07290109140315
• UDI-Public: 7290109140315
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/06/2019

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: 09/16/2019
• Initial Report FDA Received Date: 10/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1