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

Model Number GA-0006801

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

It was reported that the bricks have low power.However, system is usable and meets specification.There were no patient complications.

Manufacturer Narrative

The console was serviced by a field service engineer (fse) onsite.The four laser bricks were replaced, and the calibration parameters have returned to within the specified range.The reported low power allegation was confirmed.The coolant was drained and filled.All channels were aligned for center and mode.The console passed all tests.Based on analysis results, the issue was solved by replacing the laser bricks.A conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that the bricks have low power.However, system is usable and meets specification.There were no patient complications.

Manufacturer Narrative

The console was serviced by a field service engineer (fse) onsite.The four laser bricks were replaced, and the calibration parameters have returned to within the specified range.The reported low power allegation was confirmed.The coolant was drained and filled.All channels were aligned for center and mode.The console passed all tests.In addition, the four bricks (laser source) were returned for analysis.Visual inspection identified they were in overall good physical condition.Ends were intact with all screws in place and there was no leakage along the end cap seams.The body was clean.Based on analysis results, visual inspection identified the returned device was in good condition, however, the issue was solved by replacing the laser bricks.It is likely that the bricks were defective requiring replacement.A conclusion code of cause traced to component failure was assigned to this investigation.

Event Description

It was reported that the bricks have low power.However, system is usable and meets specification.There were no patient complications.

• Brand Name: MOSES PULSE
• Type of Device: 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: 18284628
• MDR Text Key: 330010030
• Report Number: 2124215-2023-69340
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145426
• UDI-Public: 07290109145426
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA-0006801
• Device Catalogue Number: GA-0006801
• Device Lot Number: 0000000374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1