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

Model Number	GA-0006800
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the console is working in low power.Then, case saver mode was activated and error 63 was prompted.There was no patient or procedure involved.
Additional Manufacturer Narrative
Mfr email address: (b)(4).
Event or Problem Description
It was reported that the console is working in low power.Case saver mode was activated, and error 63 was prompted.There was no patient or procedure involved.
Additional Manufacturer Narrative
Mfr email address: (b)(6).After service repair was performed by the field service engineer, the mirror of the console was returned to the lab and was visually inspected.The mirror was found to have white ash burnt marks.After the field service engineer changed the f s mirror, the issue was resolved, and the unit was within specification.Therefore, it is likely that the f s mirror was damaged and the reported allegation is confirmed.The components damaged could have affected the device performance and its integrity leading to the event experienced by the customer.Since expected or random components failures were identified without any design or manufacturing issue, the conclusion code of cause traced to component failure is selected for the complaint.
Event or Problem Description
It was reported that the console is working in low power.Case saver mode was activated, and error 63 was prompted.There was no patient or procedure involved.
Additional Manufacturer Narrative
Mfr email address: moshe.Barenboym@bsci.Com.The service repair was performed by the field service engineer.During service repair, the field service engineer (fse) removed the top covers and topped off the fluid.The top front cover was damaged which caused the inability to secure the cover to the frame causing space between the covers.The excess spacing can introduce dust or fluid into the laser.A request for a quote was sent to the technical assistance center.The engineer verified that the console was in case saver mode and found that brick 1 was at 155.The second relay mirror on the brick was replaced and both near and far alignment was performed.The aiming beam was adjusted, and the centration was verified to be good.The checklist was completed.According to the information provided, it is likely that the relay mirror was damaged.After replacement, however, the issue was resolved, and the unit was within specifications and functioning as intended.Therefore, it is likely that the damaged relay mirror could have affected the device performance leading to the event experienced by the customer.Based on the analysis results, the investigation conclusion code of cause traced to component failure was assigned to this investigation.

• 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; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17561411
• Report Number: 2124215-2023-43581
• Device Sequence Number: 12478417
• Product Code: GEX
• UDI-Device Identifier: 07290109140513
• UDI-Public: 07290109140513
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

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-0006800
• Device Catalogue Number: GA-0006800
• Device Lot Number: 0000000227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 10/17/2023; 12/18/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/14/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown