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

Model Number	GA-2006098
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the foot pedal of this device was stucked and prompted an error code 7 (footswitch pressed (during self-test & enter ready) - release the footswitch).There were no reports of patient or procedure outcome.
Additional Manufacturer Narrative
Updated block b5: describe event or problem.The console was not returned; however, the device was serviced on site by a field service engineer (fse).The fse confirmed that the foot switch was defective.The customer resolved the issue, and the machine was working fine.The malfunction found could have affected the device performance leading to the event experienced by the customer.The device history record (dhr) and service history record (shr) indicated that this device was installed on 10/11/2019 and this event occurred 5 years after the system installation.After this period, component wear, failure or damage is possible based on product use.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that an expected or random component failure was identified without any design or manufacturing issue.
Event or Problem Description
It was reported that during procedure, the foot pedal of this device was stucked and prompted an error code 7 (footswitch pressed (during self-test & enter ready) - release the footswitch).Also, noted an error code 6 (foot switch not connected).There were no reports of patient or procedure outcome.

• 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; yokneam ; IS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23100061
• Report Number: 2124215-2025-65974
• Device Sequence Number: 8685359
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: (01)07290109145990(11)190901(10)302
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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-2006098
• Device Catalogue Number: GA-2006098
• 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: 08/24/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/04/2025
• Date Device Manufactured: 09/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown