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

Model Number	GA-2009996
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an issue with the footswitch was encountered during a procedure.The procedure was aborted after the patient was sedated with general anesthesia.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
G1 mfr site facility name: corrected.H8 usage of device: corrected the component in question (footswitch) was received for analysis.Visual inspection and conductivity testing was performed.The footswitch passed the continuity test and visual inspection.The component was in good condition and exhibited no defects, however after the replacement of the foot switch, the issue was resolved, and the unit was within specification, therefore, the reported allegation was confirmed.Based on the information available, since an expected or random component failure was identified without any design or manufacturing issue, the most probable cause of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that a procedure had to be cancelled due to footswitch issues.The patient was under general anesthesia when the procedure was cancelled/aborted.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that a procedure had to be cancelled due to footswitch issues.The patient was under general anesthesia when the procedure was cancelled/aborted.There were no patient complications.This event is being reported for aborted/ cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.However, a replacement footswitch was shipped to the customer.It is likely that the foot switch issue could have affected the device performance leading to the event experienced by the customer.The reported complaint was confirmed.Based on the information available, since an expected or random component failure was identified without any design or manufacturing issue, the most probable cause of cause traced to component failure was assigned to this investigation.

• Brand Name: MOSES PULSE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; yokneam ind. park; hakidma 6; yokneam 20692 03; IS 2069203
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18432594
• Report Number: 2124215-2023-74818
• Device Sequence Number: 7633181
• Product Code: GEX
• UDI-Device Identifier: 07290109145518
• UDI-Public: 07290109145518
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2024

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-2009996
• Device Catalogue Number: GA-2009996
• Device Lot Number: 0000001097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 05/13/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/20/2024; 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown