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

Model Number	GA-0006600
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a surgical procedure, while the patient was sedated, the power key part was spinning freely.The procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.
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.During functional evaluation of the console, it was identified that the power cable was twisted when the power key was forced to turn from a free-spinning state.The fse proceeded to replace the key switch in the laser console and finally, no further issues were identified during service, and the console was confirmed to be fully functional after the replacement.It is likely that the defective key switch could have affected the device performance leading to the reported event.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during preparation for a surgical procedure, while the patient was sedated, the power key part was spinning freely.The procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.

• 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 street 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23163810
• Report Number: 2124215-2025-66653
• Device Sequence Number: 8954033
• Product Code: GEX
• UDI-Device Identifier: 07290109140551
• UDI-Public: (01)07290109140551(11)141028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/20/2025

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: GA-0006600
• Device Catalogue Number: GA-0006600
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/28/2025
• Supplement Report FDA Received Date: 11/20/2025
• Date Device Manufactured: 10/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown