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

Model Number	GA-0006000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber was connected to the console, it was able to be used it for a while but at one point at the machines connector there was a spark.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
The console was not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.During functional evaluation of the console, it was identified that the fiber optic cable was damaged; this cable was replaced, and the noise seems to have disappeared.Therefore, the reported complaint was confirmed.According to the information provided, after the fiber optic cable was replaced, the issue was resolved, and the unit was within specification.As a result, the console was functioning as intended.The malfunction found could have affected the device performance leading to the event experienced by the customer.Labeling review confirmed the ifu includes appropriate warnings and specific indications related to the fiber connector security, such as: warning: when removing the protective cap, hold the laser connector, not the strain relief or fiber optic cable.Pulling on the strain relief or fiber optic cable may damage the delivery system and result in unintended laser exposure.If the laser connector is not properly seated and securely screwed into the fiber port, a message appears on the control screen: connect the fiber properly.Safety interlocks: the laser system has safety interlocks on the optical fiber laser connector.Laser energy emission is disabled if a fiber is not connected.Based on review of all information available and analysis results, since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that after the fiber was connected to the console, the console was able to be used for a while.However, after being used for a while, there was a spark at the consoles connector.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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: 21858050
• Report Number: 2124215-2025-23308
• Device Sequence Number: 7981989
• Product Code: GEX
• UDI-Device Identifier: 07290109140544
• UDI-Public: (01)07290109140544(11)151105(10)619
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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-0006000
• Device Catalogue Number: GA-0006000
• 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: 03/25/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 11/05/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown