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

Model Number	GA-2006098
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ring around the fiber port was missing, and the fibers are not connecting.The procedure was not completed due to another reason.There was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The console was not returned for analysis; however, a field service engineer (fse), conducted an onsite visual inspection of the fiber port.The visual inspection confirmed that the ring around the fiber port was missing, and fibers were not connecting thus confirming the reported event.Based on the fse evaluation, after performing adjustment to the fiber port component, the console was able to be fixed.Adjustments are part of the activities performed by the fse during preventive maintenance; therefore, the caused of the reported event was likely due to improper routine or preventative maintenance.
Event or Problem Description
It was reported that the ring around the fiber port was missing, and fibers are not connecting.The procedure was not completed due to another reason and there were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.

• Brand Name: PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidman st. 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; hakidman st. 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17643110
• Report Number: 2124215-2023-46385
• Device Sequence Number: 8059615
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown