MAUDE Adverse Event Report: LUMENIS LTD Lumenis Moses 550 D\F\L; powered laser surgical instrument

Model Number	1912-10
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event date was not available to boston scientific.Because the event date is unknown at this time, an estimated date was provided.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during procedure, the fiber connector overheated and smoke was seen coming from the connector.The fiber broke at the proximal part when it was being changed.The procedure was completed with a fiber replacement.There were no patient complications.

• 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: 25733134
• Report Number: 2124215-2026-36258
• Device Sequence Number: 16065898
• Product Code: GEX
• UDI-Device Identifier: 07290109143453
• UDI-Public: (01)07290109143453(17)280825(10)10912602
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2026

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: 0010912602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: Not provided; 09/10/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 09/03/2026; 10/02/2026
• Date Device Manufactured: 02/24/2026
• 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