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

Model Number	UNK-P-SLIMLINE_FIBERS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, the debris shield got burnt during a procedure.The fiber and the debris shield were replaced, and immediately after restarting the procedure, an abnormal noise was heard coming from the fiber connection point, and then the fiber broke at the connector.The procedure was completed using another of same device.There were no patient complications.This complaint refers to the fiber that broke.
Additional Manufacturer Narrative
Correction to field d1.Brand name.Correction to field d4.Model number, catalog number and unique identifier (udi).
Event or Problem Description
It was reported that, the debris shield got burnt during a procedure.The fiber and the debris shield were replaced, and immediately after restarting the procedure, an abnormal noise was heard coming from the fiber connection point, and then the fiber broke at the connector.The procedure was completed using another of same device.There were no patient complications.This complaint refers to the fiber that broke.

• Brand Name: SLIMLINE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21313174
• Report Number: 2124215-2025-05633
• Device Sequence Number: 8168930
• Product Code: GEX
• UDI-Device Identifier: 07290109140247
• UDI-Public: 07290109140247
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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-SLIMLINE_FIBERS
• Device Catalogue Number: UNK-P-SLIMLINE_FIBERS
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown