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

Model Number GA-2003477

Device Problems Defective Device (2588); Output below Specifications (3004)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that the blast shield lens was burnt during the procedure and the blast shield lens and probe were replaced but the output seems weak.The procedure was completed with a non-bsc product without patient complications.

Manufacturer Narrative

The console was not returned for analysis; however, a field service engineer (fse), conducted an onsite visual inspection of the console.While performing the visual inspection the fse found the probe and two blast shields to be defective.After replacing the two blast shield lens assemblies, performing a laser optical axis adjustment, and output check the reported complaint of low power output was resolved.Based on the field service performed, it is most likely that the damaged probe and debris shields could have affected the device performance thus confirming the reported finding.H3 other text : device remains at health care facility.

Event Description

It was reported that the blast shield lens was burnt during the procedure and the blast shield lens and probe were replaced but the output seems weak.The procedure was completed with a non-bsc product without patient complications.

• Brand Name: MOSES PULSE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidman st. 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS LTD; yokneam industrial park; hakidm; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17909371
• MDR Text Key: 325357782
• Report Number: 2124215-2023-55968
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145440
• UDI-Public: 07290109145440
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA-2003477
• Device Catalogue Number: GA-2003477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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