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	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility directly for additional information.Despite reasonable attempts, no additional information had been provided.It is not clear if the event happened during a procedure or even if a patient was involved.A review of the subject device dhr confirmed that the subject device was manufactured 3-mar-2013 and installed at the customer's site on 11-mar-2013.A lumenis service engineer visited the site after the reported event and examined the laser system.The engineer confirmed the system does not power up and found damaged live wire in the wall plug.Repaired and reconnected live wire and after verifying the system is working within manufacturer specifications the system was returned to the facility safe and ready for use.A review of system risk files found the risk of system failure (b)(4) 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.Lumenis has been unable to obtain additional information to date regarding the circumstances surrounding this event, not even if a patient was involved.Due to a lack of additional information and in an abundance of caution lumenis is reporting this event.Should additional relevant details become available; the complaint file and medwatch report will be updated accordingly.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 foreign user facility reported that mains circuit breaker tripping out during a procedure in which a lumenis versapulse 100w was being utilized.When mains came back online, system did not powered.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: 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: 11256840
• Report Number: 3004135191-2021-00004
• Device Sequence Number: 3692232
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: 07290109140551
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/31/2021

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 POWERSUITE 100W
• Device Catalogue Number: GA-0006500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1