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	12/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3 manufacturer email moshe.Barenboym@bsci.Com.
Event or Problem Description
It was reported that that during introduction, the self test unit failed.The procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was unknown.
Additional Manufacturer Narrative
D3 manufacturer email (b)(6).Boston scientific corporation (bsc) received additional information clarifying the initial awareness date of mfr report submitted on 31aug2023.The initial notification from a non-bsc affiliate distributor to our bsc affiliate was initially received on 9-aug-2023.As such, the bsc aware date of 9-aug-2023 would make the report due 08-sep-2023; therefore, the mfr report submitted on 31aug2023 was not filed beyond the 30 days from initial bsc awareness date.
Event or Problem Description
It was reported that that during introduction, the self test unit failed.The procedure was not completed due to this event.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient whose sedation status was 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.; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17664785
• Report Number: 2124215-2023-46995
• Device Sequence Number: 7124054
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: 05/16/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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