MAUDE Adverse Event Report: LUMENIS LTD ULTRAPULSE DUO; POWERED LASER SURGICAL INSTRUMENT

Model Number	UNK-P-ULTRAPULSE_DUO
Medical Device Problem Codes	Smoking (1585); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console alignment is off and there is a burning smell at first use after repair.There was no patient involvement.
Event or Problem Description
It was reported that the console alignment is off and there is a burning smell at first use after repair.There was no patient involvement.
Additional Manufacturer Narrative
Correction to field g1: mfr site facility name.Correction to field d1: brand name.Correction to field d4: model number.Correction to field d4: catalog number.
Additional Manufacturer Narrative
The console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, there was found misalignment on newly fitted articulated arm.Due to this, the original articulated arm was refitted.Therefore, the reported allegation was confirmed leading to the reported event.After the field service engineer performed the alignment, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Regarding the allegation of burning smell, it was not confirmed during the service.
Event or Problem Description
It was reported that the console alignment is off and there is a burning smell at first use after repair.There was no patient involvement.

• Brand Name: ULTRAPULSE DUO
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20669283
• Report Number: 2124215-2024-70616
• Device Sequence Number: 17951744
• Product Code: GEX
• UDI-Device Identifier: 07290109145419
• UDI-Public: 07290109145419
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K203544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: UNK-P-ULTRAPULSE_DUO
• Device Catalogue Number: UNK-P-ULTRAPULSE_DUO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 02/05/2025; 02/27/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 02/26/2025; 03/24/2025
• Date Device Manufactured: 11/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown