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

Model Number	GA-0006000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the laser continues firing even after the foot switch is released.No patient was involved.
Additional Manufacturer Narrative
This console was serviced at the customer's site.The field service engineer (fse) checked the system and noted debris was causing the foot-switch to be jammed.The reported event was confirmed.Clearing the foot-switch jam resolved the issue.The console was checked using testing fiber and was found to be working without issue.After the fse performed the correct cleaning of the foot-switch, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.Therefore, the investigation was assigned the most probable conclusion code of cause traced to component failure.
Event or Problem Description
It was reported that the laser continues firing even after the foot switch is released.No patient was involved.

• Brand Name: PULSE
• 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: 22091163
• Report Number: 2124215-2025-33980
• Device Sequence Number: 12767969
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: (01)07290109140544(11)130827(10)329
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

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: GA-0006000
• Device Catalogue Number: GA-0006000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/30/2025
• Date Device Manufactured: 08/27/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown