MAUDE Adverse Event Report: LUMENIS LTD VERSAPULSE POWERSUITE; POWERED LASER SURGICAL INSTRUMENT

Model Number	0638-803-01
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device cutting efficiency was low and that there was an energy delivery output/failure.There was no patient or procedure involved.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.However, the device was serviced on-site by a field service engineer (fse).The on-site inspection found that the first channel flash lamp was not functioning properly.The fse replaced the flash lamp, checked, and now it's working properly.All the parameters were checked and tested, and everything was working fine as per the checklist with no issues.The blast shield was checked, and it looked fine.Coolant and fiber were good.Mirrors were checked and everything looked fine with no spots on the mirror.Lastly, the fse checked all the alignment and calibrated the machine.The defective flash lamp that was identified could have affected the device performance leading to the event experienced by the customer.Based on all available information, since an expected or random component failure was identified without any design or manufacturing issue, boston scientific concluded that the cause of the complaint was traced to component failure.
Event or Problem Description
It was reported that the device cutting efficiency was low and that there was an energy delivery output/failure.There was no patient or procedure involved.

• Brand Name: VERSAPULSE POWERSUITE
• Common Device Name: 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: 23982133
• Report Number: 2124215-2026-00761
• Device Sequence Number: 21508760
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2026

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: 0638-803-01
• Device Catalogue Number: 0638-803-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/23/2026; 06/18/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/12/2026; 07/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown