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

Model Number	ULTRAPULSE TOTAL FX
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 4-feb-2019 (b)(4) was received by lumenis cru.The ce resolution was to send a comm.Cable as a replacement.The shipment was done on the same day.On 12-feb-2019 the current complaint was opened as an adverse event due to the same complaint description as (b)(4): laser not recognizing scanner.The ce talked with the facility and has decided to send a replacement scanner.Product investigation was submitted in order to understand the scanner recognition issues.According to ultrapulse user manual 0637-129-01, revision h: "before replacing any scanning accessory at the endjoint of the articulated arm (deepfx, encore cpg, etc.), the scanner software module needs to be paused in order to prevent possible damage to the system.Pause the scanner software module by pressing the (pause) button on the options screen.Disconnect the communication cable from the scanning accessory and disconnect the accessory from the articulated arm.Connect the desired scanning accessory to the articulated arm, and connect the communication cable to the accessory.To restart the scanner software module after you have connected the new scanning accessory to the endjoint, press the (restart) button on the options screen." when the user is not following these instruction, error 235 is displayed.Based on the above it can be concluded that incorrect use of the scanner is the cause of the reported error and recognition issue.It can be concluded that no injury occurred in this event.Lumenis is reporting this adverse event in abundance of caution because the procedure was canceled and the patient was awakened from general anesthesia.
Event or Problem Description
User facility reported that the planned procedure with the subject device could not be performed due to error 235.The patient was under general anesthesia and should be awakened.

• Brand Name: ULTRAPULSE TOTAL FX
• Common Device Name: CO2 SURGICAL DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ,; IS 20692,
• MDR Report Key: 8418698
• Report Number: 3004135191-2019-00034
• Device Sequence Number: 1516225
• Product Code: GEX
• UDI-Device Identifier: 07290109140490
• UDI-Public: 7290109140490
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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: 02/12/2019
• Initial Report FDA Received Date: 03/13/2019
• 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