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

Model Number	GA-2006378
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D3/g1 additional email: moshe.Barenboym@bsci.Com.
Event or Problem Description
It was reported that, during a procedure, the debris shield was moving a lot and the console did not detect it; due to this, the laser stopped working and the surgery was aborted.No patient complications were reported.This event is being reported for aborted procedure with a patient under anesthesia or sedation status unknown.
Event or Problem Description
It was reported that, during a procedure, the debris shield was moving a lot and the console did not detect it; due to this, the laser stopped working and the surgery was aborted.No patient complications were reported.This event is being reported for aborted procedure with a patient under anesthesia or sedation status unknown.
Additional Manufacturer Narrative
The console or components were 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 reported debris shield movement was caused by the detecting switch was loose, requiring adjustment.The fse proceeded to perform the adjustment the debris shield, detecting the switch.No further issues were identified during service, and the console was confirmed to be fully functional after repairs and power tests.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to maintenance 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): 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: 16873705
• Report Number: 2124215-2023-20720
• Device Sequence Number: 5830049
• Product Code: GEX
• UDI-Device Identifier: 07290109144665
• UDI-Public: 07290109144665
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/26/2023

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-2006378
• Device Catalogue Number: GA-2006378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown