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

Model Number	AC-1001636
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber broke into two.There was no further information provided on the procedure or patient outcome.
Additional Manufacturer Narrative
The device has not been returned to bsc for evaluation; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that the fiber broke into two.There was no further information provided on the procedure or patient outcome.

• Brand Name: SLIMLINE SIS LP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LIGHTGUIDEOPTICS INTERNATIONAL LTD; celtniecibas str 8; livani LV-53 16; LG LV-5316
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21315430
• Report Number: 2124215-2025-06187
• Device Sequence Number: 8019937
• Product Code: GEX
• UDI-Device Identifier: 07290109144627
• UDI-Public: 07290109144627
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2025

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: AC-1001636
• Device Catalogue Number: AC-1001636
• Device Lot Number: 0003970922
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 03/10/2025
• Date Device Manufactured: 09/23/2022
• 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