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

Model Number	GA-2006098
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer is getting foot pedal errors.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
D3.Manufacturer email: moshe.Barenboym@bsci.Com.
Event or Problem Description
It was reported that the customer is getting foot pedal errors.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
D3.Manufacturer email: (b)(6).Upon receipt of the foot switch at our quality assurance laboratory, the device was thoroughly analyzed.Visual analysis identified the foot switch assembly was in overall good physical condition.The foot switch guard show some chipped paint on the edges along with scuff marks consistent with normal usage wear.The foot pedal pressed down smoothly and returned to the open position without any issues.One of the rubber feet was missing.The connector was in pieces and the back screw on the piece was disconnected.The cable and pin fitting was held in place with black electrical tape.Outside, the metal shield was missing and the cable was a little twisted.Based on the information available, and the analysis results of the foot switch, it is probable that the damage identified on the foot switch caused or contributed to the reported errors.

• 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: 17444227
• Report Number: 2124215-2023-40756
• Device Sequence Number: 2735509
• Product Code: GEX
• UDI-Device Identifier: 07290109145990
• UDI-Public: 07290109145990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 09/14/2023

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
• Device Lot Number: 0000000358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown