MAUDE Adverse Event Report: LUMENIS LTD. FIBERLASE- CO2 FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	FIBERLASE ENDURE
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 10-jan-2019, lumenis communicated with a representative who was onsite at the time of the incident.The rep had reported that during the case the laser was working fine and the case was proceeding with a second fiber.A discussion with the crna had led the representative to believe that while the crna was trying to kink the iv tube during medication of the patient, he likely kinked the fiber as well, which led to the inadvertent break and the beam escaping the broken area while the surgeon fired the laser.It had further been reported that the crna's burn has "healed well".Although the fiber had not been returned to lumenis for evaluation, lumenis believes the fiber break was caused by an inadvertent user error.Lumenis believes the most probable root cause to be "operational context having caused or contributed to the event"; lumenis believes the problem was related to the operator's technique or use environment, most likely caused by the user inadvertently kinking the fiber while kinking the iv tube administering medication to the patient.Lumenis has determined this event to be solely the result of user error with no other performance issues, and although the information received to date does not confirm that a serious injury occurred, because of the lack of information regarding the chance of permanent impairment, the company is reporting the event in an abundance of caution.Should additional information become available, the complaint record will be updated accordingly and a follow-up medwatch report will be submitted.
Event or Problem Description
A user facility reported that during a robotic myomectomy procedure in which a lumenis ultrapulse duo was being used with a lumenis fiberlase fiber and robotic drop-in-guide (lumenis dig), the fiber had broken and burned the nurse anesthetist (crna).A superficial burn was observed on the left hand of the crna.As there were no error codes with the laser, and no malfunction observed, a second fiber was prepared to continue the case.The clinical operating room director came into the room and asked the surgeon to discontinue using the laser, although the surgeon wanted to continue the case with the laser.A different device was used to complete the procedure.No injury occurred with the patient, and the person that was burned allegedly did not sustain a serious injury.

• Brand Name: FIBERLASE- CO2 FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma street; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 8285020
• Report Number: 3004135191-2019-00003
• Device Sequence Number: 2463241
• Product Code: GEX
• UDI-Device Identifier: 07290109142012
• UDI-Public: 07290109142012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/29/2019

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: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: FIBERLASE ENDURE
• Device Catalogue Number: AC-1059590
• Device Lot Number: 10590618
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/29/2019
• 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
• Patient Age: 36 YR