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

Model Number	GA-1008944
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the key switch was broken.The black connection port has been broken from inside the console.The procedure was cancelled.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The console was field service at the user's facility, the key witch was damaged.After replacing the key witch, the issue was resolved, and the console was within specification and functioning as intended.In addition, the key switch was receipt at our post market quality assurance laboratory, visual inspection identified that the key switch was broken into two pieces.Therefore, the reported event was confirmed.Correction to field g2: report source.
Event or Problem Description
It was reported that the key switch was broken.The black connection port has been broken from inside the console.The procedure was cancelled.There were no patient complications reported.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; 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: 19802191
• Report Number: 2124215-2024-44809
• Device Sequence Number: 20681208
• Product Code: GEX
• UDI-Device Identifier: 07290109145969
• UDI-Public: 07290109145969
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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-1008944
• Device Catalogue Number: GA-1008944
• Device Lot Number: 0000003078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown