MAUDE Adverse Event Report: LUMENIS LTD LUMENIS MOSES 550 D\F\L; POWERED LASER SURGICAL INSTRUMENT

Model Number	1912-10
Medical Device Problem Codes	Overheating of Device (1437); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during homium laser enucleation of the prostate (holep) procedure to treat stones, a burning smell and smoke were noticed to be coming from the plastic probe of the fiber connector while the fiber was outside the patient.When attempting to replace the fiber, the probe broke, and it was noticed that the plastic connection had melted.The procedure was completed with a fiber replacement.There were no harms to the patient and operator, and there were no patient complications.
Additional Manufacturer Narrative
The device was not available for analysis; therefore, no physical or visual analysis of the product could be performed.The allegations of "fiber separated from connector" and "overheating of connector" cannot be confirmed.The labeling review found that the product ifu states, "warning - a damaged fiber may cause accidental laser exposure or injury to the treatment room personnel or patient, and/or fire in the treatment room" and "inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement." a device history record was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could have contributed to the complaint.A risk review was completed and confirmed that the events of "fiber separated from connector" and "overheating of connector" were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information provided, the most probable cause of the reported issue cannot be established due to lack of evidence.Since the investigation findings do not lead to a clear conclusion about the cause of the reported event, the investigation conclusion code selected for this complaint is unable to exclude device problem which states "the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.".

• Brand Name: LUMENIS MOSES 550 D\F\L
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): ADVANCED FIBER TOOLS GMBH; bornheimer str 4; mittweida 09468 ; GM 09468
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24706568
• Report Number: 2124215-2026-16770
• Device Sequence Number: 10439891
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)280304(10)15122508
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 1912-10
• Device Catalogue Number: 1912-10
• Device Lot Number: 0015122508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 09/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown