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

Model Number GA-0006802

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

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that the right pedal on the foot pedal was not working.The customer was advised to turn the console off, turn the key off, turn the circuit breaker off, and then to turn everything back on.The customer turned everything off as instructed and then turned everything back on.However, the right pedal still would not work.The foot switch was then unplugged and plugged back in.The same device issue continued.It was also reported that there was an energy delivery output/failure.The customer had an extra foot switch on hand that could be used.There were no patient complications.

Manufacturer Narrative

The console was not returned for analysis; however, this console was serviced at the customer's facility.The foot switch was replaced.After the foot switch was replaced, the reported device issue was resolved and the unit was within specifications.Based on the information available, it is probable that the foot switch was damaged which resulted in the reported energy delivery output/failure.

• 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: 18768424
• MDR Text Key: 336796614
• Report Number: 2124215-2024-10868
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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
• Device Lot Number: 0000000107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male