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	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that during a ureteroscopy procedure in which a lumenis pulse 120 laser was being utilized, the display presented error "laser overheated".The user attempted to restart the laser several times to no avail.Unable to complete the procedure, a stent was used and the patient was awakened from general anesthesia and the case needed to be rescheduled.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 11-oct-2021 and installed at the customers (b)(6) 2022.A lumenis service engineer visited the after the reported event and examined the laser system.The engineer found that the pump made excessive noise and water level dropped below normal.Added coolant to level that allowed the pump to operate without excessive noise.The engineer ordered a replacement chiller as there is extra pressure in the cooling line causing the reservoir to be over full and some water comes out of the pressure release valve when the system is moved.The engineer returned and replaced the chiller added distilled water and replaced debris shields.Verified the system is working within manufacturer specifications and is ready for use.A two year historical review of similar complaints revealed that the same chiller malfunction during a procedure has not led to serious injury in the past.To date lumenis is unaware of such events ever having led to injury.A review of subject device product risk file (rd-1124690_ak) 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 has been characterized and documented as acceptable within a full risk assessment.In this case, the patient was awakened from anesthesia, the procedure was cancelled, 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 event.The failed chiller 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.34-01-04-00) and per post marketing surveillance procedure (doc no.1005539).

• 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 ; IS 20692
• Manufacturer (Section G): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• Manufacturer Contact: yoav wimisner ; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 14976920
• Report Number: 3004135191-2022-00018
• Device Sequence Number: 12017429
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2022

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-0006802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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