MAUDE Adverse Event Report: LUMENIS LTD LUMENIS PULSE 120H; POWERED LASER SURGICAL INSTRUMENT

Model Number	GA-0008700D
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device did not have enough power when performing fine dusting.The procedure was completed using another of the different device.There were no patient complications.
Event or Problem Description
It was reported that the device did not have enough power when performing fine dusting.The procedure was completed using another of the different device.There were no patient complications.
Additional Manufacturer Narrative
Updated block e1: initial reporter first name, last name, and phone number.The console device was not returned to the service center but was serviced on-site at the customer's facility by a field service engineer (fse).The fse confirmed the reported issue of the device low power.The cooling water level was below the minimum and was refilled.The di filter connection was loose and has been repaired.Hr mirror brick 2 was defective (minor burn-in) and was replaced.Optical alignment was checked and readjusted.Output energy was checked and adjusted to the standard range.A test run was performed, and no errors were detected.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) indicate that this p120 was installed on 26 may 2025.The console was fully functional with no issues from that date until the complaint date.A review of the device's instructions for use (ifu) was performed, and it includes specific warnings related to "low power" such as "energy detectors check and calibration must be performed by a qualified technician with experience in working with laser equipment.Questions regarding this procedure should be referred to your local lumenis representative" there is no indication that the device was not used in accordance with the ifu.The ifu has no issues with translation, wording, or graphics; therefore, no revision is required.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that expected or random component failures were identified, with no design or manufacturing issues found.
Additional Manufacturer Narrative
Updated block d4: unique identifier (udi) #.Updated block e1: initial reporter first name, last name, and phone number.The console device was not returned to the service center but was serviced on-site at the customer's facility by a field service engineer (fse).The fse confirmed the reported issue of the device low power.The cooling water level was below the minimum and was refilled.The di filter connection was loose and has been repaired.Hr mirror brick 2 was defective (minor burn-in) and was replaced.Optical alignment was checked and readjusted.Output energy was checked and adjusted to the standard range.A test run was performed, and no errors were detected.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) indicate that this p120 was installed on (b)(6) 2025.The console was fully functional with no issues from that date until the complaint date.A review of the device's instructions for use (ifu) was performed, and it includes specific warnings related to "low power" such as "energy detectors check and calibration must be performed by a qualified technician with experience in working with laser equipment.Questions regarding this procedure should be referred to your local lumenis representative" there is no indication that the device was not used in accordance with the ifu.The ifu has no issues with translation, wording, or graphics; therefore, no revision is required.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating that expected or random component failures were identified, with no design or manufacturing issues found.
Event or Problem Description
It was reported that the device did not have enough power when performing fine dusting.The procedure was completed using another of the different device.There were no patient complications.

• Brand Name: LUMENIS PULSE 120H
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; yokneam industrial park; 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: 22644991
• Report Number: 2124215-2025-51155
• Device Sequence Number: 12952519
• Product Code: GEX
• UDI-Device Identifier: 07290109147215
• UDI-Public: (01)07290109147215(11)220214
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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-0008700D
• Device Catalogue Number: GA-0008700D
• 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: 07/08/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 11/12/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 11/13/2025; 12/03/2025
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male