MAUDE Adverse Event Report: LUMENIS LTD. VERSAPULSE P20; POWERED LASER SURGICAL INSTRUMENT

Model Number	VERSAPULSE P20
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the subject device dhr confirmed that the subject device was installed at the customer's site on 24-jul-2002.On 23-jan-2013 lumenis issued, a system manufacturing discontinuation note which stated that the technical support will continue till 23-jan-2020.Therefore as of 23-jan-2020, the system is no longer serviceable.A review of system risk files identified the risk of device malfunction (1007141_c - risk # 9.1.1) which has the potential to lead to "inability to complete treatment which may require alternative treatments".The risk likelihood has been quantified and found to be negligibly small, and the risk has been characterized and documented as acceptable within full risk assessment.A two-year historical review of similar complaints revealed that system failure during a procedure has not led to serious injury.In this case, the patient was awakened from anesthesia, the procedure was cancelled, although there was no report of injury associated with this event, lumenis believes that subjecting a patient to another round of anesthesia carries inherent risks, and in an abundance of caution, lumenis is reporting this event to the fda.According to the gso expert based on the age of the system, wear could have likely played a role in the failure.Since this product is no longer manufactured/serviceable, 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 stone procedure in which a lumenis versapulse p20 laser system was to be utilized, error message appeared on the screen.Unable to complete the procedure, the patient was awakened from general anesthesia and the case needed to be rescheduled.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.The procedure was completed at another day without any patient complications.

• Brand Name: VERSAPULSE P20
• 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: 12135312
• Report Number: 3004135191-2021-00043
• Device Sequence Number: 4130958
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: 07290109140544
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: VERSAPULSE P20
• Device Catalogue Number: VPPS20
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1