MAUDE Adverse Event Report: LUMENIS LTD. LUMENIS PULSE 30H; HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG)

Model Number	LUMENIS PULSE 30H
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
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.The system was manufactured on 12-feb-2019 and installed at the customers site on 27-aug-2019.A lumenis service engineer visited the site four (4) days after the reported event.Upon troubleshooting, a faulty lvps was found and a new part was ordered.The lvps is expected to be returned to lumenis for evaluation.The engineer returned and replaced the lvps and after reconfirming it's operation, the engineer returned the system to the facility in working order.A review of system risk files ((b)(4)) revealed risk #(b)(4) " low voltage power supply failure" which have the potential to lead to ineffective treatment which may require re-operation -or- prolonged procedure.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 lvps is expected to be returned to the manufacturer for analysis.Upon receipt and completion of the failure analysis of the lvps, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
A user facility reported that during a bladder stone procedure in which a lumenis pulse 30h was being utilized, "the fan started going very fast and a strong smell/odor came out of the system.Suddenly the system stopped and displayed error 26".Unable to complete the procedure, 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.

• Brand Name: LUMENIS PULSE 30H
• Common Device Name: HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG)
• Manufacturer (Section D): LUMENIS LTD.; 6 hakidma st.; po box 240; yokneam, 20692 ; IS 20692
• MDR Report Key: 9303161
• Report Number: 3004135191-2019-00125
• Device Sequence Number: 1864077
• Product Code: GEX
• UDI-Device Identifier: 07290109140698
• UDI-Public: 07290109140698
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2019

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 30H
• Device Catalogue Number: GA-2006098
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1