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

Model Number	0638-804-00
Medical Device Problem Codes	Nonstandard Device (1420); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during maintenance, found that the energy was 70% of the normal value, there were bad points in the first laser rod, the low end of the fourth channel was 51 and the energy of the third laser cavity was low.There were no patient or procedure was involved.
Additional Manufacturer Narrative
The console or components were not returned for analysis; however, the console was evaluated by a field service engineer (fse) at the customer site.Upon investigation of this device, it was recommended the replacement of the laser rod and the optic bricks/cavities to resolve the issue.Based on this information the reported allegation was confirmed.The malfunction found could have affected the device performance leading to the event experienced by the customer.A risk review was completed and confirmed that the event of low power is defined in the risk documentation.Since an expected or random component failure was identified without any design or manufacturing issue, the investigation conclusion code selected for this complaint is cause traced to component failure.
Event or Problem Description
It was reported that during maintenance, found that the energy was 70% of the normal value, there were bad points in the first laser rod, the low end of the fourth channel was 51 and the energy of the third laser cavity was low.There were no patient or procedure was 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: 24354984
• Report Number: 2124215-2026-08710
• Device Sequence Number: 13210225
• Product Code: GEX
• UDI-Device Identifier: 07290109140575
• UDI-Public: (01)07290109140575(11)070806
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/26/2026

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: 0638-804-00
• Device Catalogue Number: 0638-804-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2007
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown