MAUDE Adverse Event Report: LUMENIS LTD. ULTRAPULSE TOTAL FX; CO2 SURGICAL DEVICE, PRODUCT CODE

Model Number	ULTRAPULSE TOTAL FX
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lumenis investigated the reported event by contacting the user facility to obtain patient information, treatment settings, incident forms with photos, which weren't provided as no injury had occurred.The patient was awakened during the procedure and the treatment was re-scheduled.The customer said that they were performing the procedure when the system started showing error 35.A lumenis service engineer wasn't scheduled as no payment was made by the billable customer.Energy integrators deviation.If the average energy of a series of laser shots as measured from one detector shows a relative deviation from the average energy as measured from another safety detector, it will then trigger a fault.2.Go to service screen # 1, press the attenuator button, and verify that cmnd and hdwr are defined as open.If one of them remains clsd, the attenuator pc board must be replaced.No clinical evaluation was done as no injury was reported to lumenis.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 as an adverse event.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the compliant device, if there is any further relevant information from that review, a supplemental medwatch will be filed.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.34-01-04-00) and per post marketing surveillance procedure (doc no.1005539).
Event or Problem Description
Lumenis received a report of an adverse event following treatment with ultrapulse totalfx.The patient was awakened during treatment and was rescheduled for a different time.

• Brand Name: ULTRAPULSE TOTAL FX
• Common Device Name: CO2 SURGICAL DEVICE, PRODUCT CODE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ,; IS 20692,
• MDR Report Key: 10957786
• Report Number: 3004135191-2020-00084
• Device Sequence Number: 11605197
• Product Code: GEX
• UDI-Device Identifier: 07290109141596
• UDI-Public: 07290109141596
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: ULTRAPULSE TOTAL FX
• Device Catalogue Number: GA-0000530
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other