MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 120H; HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE

Model Number	LUMENIS PULSE 120H
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A foreign user facility reported that during a lithotripsy procedure in which a lumenis pulse 120 laser was being utilized, the unit started smoking.The facility shut off the unit and did not use it.After ten minutes delay to clear the operating room of smoke, a second laser was brought in to complete the procedure.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.
Additional Manufacturer Narrative
A review of the subject device dhr confirmed that the subject device was manufactured and tested according to relevant procedures, tested before release, and shipped according to manufacturer's specifications.Device was manufactured on 10-jul-2018 and installed at the customers site on (b)(6) 2018 a review of subject device product risk file ((b)(4)) revealed risk # 2.4.2; "system failure" which has the potential to lead to prolonged procedure -or- ineffective treatment which may require re-operation.The risk has been quantified and found to be remote, and the risk likelihood has been characterized and documented as acceptable within a full risk assessment.A lumenis service engineer visited the site and found dc to dc board to be defective a substitute device was given to the user and the system was taken for repair.A two year historical review of similar complaints revealed that the same malfunction of dc to dc board failure has not led to serious injury in the past.In this case an alternate laser was brought in to complete the case with no complications to the patient.Although the device malfunction did not cause or contribute to any change in the patient's condition, it is uncertain if the user facility had to use the alternate device as intervention to prevent permanent damage.In an abundance of caution lumenis is reporting this malfunction to the fda.However, lumenis regulatory has determined it is not reportable in (b)(6).The failed dc to dc board is expected to be returned to lumenis for analysis.Upon receipt and completion of the failure analysis of the device, if there is any further relevant information from that review, a supplemental mdr will be filed.Lumenis 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)).

• Brand Name: LUMENIS PULSE 120H
• Common Device Name: HOLMIUM (HO:YAG) SURGICAL LASERS AND DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 04; IS 2069204
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692-04 ; IS 2069204
• MDR Report Key: 13886210
• Report Number: 3004135191-2022-00009
• Device Sequence Number: 11013126
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 03/24/2022

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: LUMENIS PULSE 120H
• Device Catalogue Number: GA-2003476
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown