MAUDE Adverse Event Report: LUMENIS LTD VersaPulse PowerSuite; Powered Laser Surgical Instrument

Model Number	0638-804-01
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation prior to a procedure, when booting up the console to test fire, an error message appeared stating " "maximum available ho:yag pulse rate reduced to 10hz" and "maximum available ho:yag power reduced to 20w".The technician restarted the console but error all lasers are malfunctioning, please call coherent service" appeared.There were no patient complications, the case had to be cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
The device component was not returned for analysis; therefore, neither a physical nor a visual analysis was performed.The reported allegation of device displays error message could not be confirmed.A review of the device history record (dhr) was performed.The review of the dhr identified that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A risk review was completed and confirmed that the event of surgical procedure delayed is defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established since the most probable cause of the reported issue could not be established due to lack of evidence.

• 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: 25897145
• Report Number: 2124215-2026-39377
• Device Sequence Number: 10171323
• Product Code: GEX
• UDI-Device Identifier: 07290109146218
• UDI-Public: (01)07290109146218(11)151203
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K170121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 0638-804-01
• Device Catalogue Number: 0638-804-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 12/03/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown