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

Model Number GA-0006802

Device Problem Output below Specifications (3004)

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

Event Date 10/06/2023

Event Type  malfunction  

Event Description

It was reported that the device had low power output requiring recalibration.There was no error courtesy message prompted by the console.No patient involved at the time of the console finding.

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 debris shield with pitting in the laser.After replacing the blast shield the reported complaint of low power output was resolved.In addition, the customer was shown how to replace the debris shields, if in case, the reported issue occurs again.Based on the field service performed, it is most likely that the damaged debris shield could have affected the device performance thus confirming the reported finding.H3 other text: the device is capital equipment.

Event Description

It was reported that the device had low power output requiring recalibration.There was no error courtesy message prompted by the console.No patient involved at the time of the console finding.

• 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; hakidman st. 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18007995
• MDR Text Key: 326770703
• Report Number: 2124215-2023-59306
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 07290109145525
• UDI-Public: 07290109145525
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA-0006802
• Device Catalogue Number: GA-0006802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1