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

Model Number	0638-803-01
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon field service of this console, it was identified that the device was coming up in case server mode.Additionally, it was found that optical relay and high reflector mirrors on channel 2 and 3 were burnt.After adjusting the resonator channel it was also identified that the high reflector mirror on channel 3 was causing a bad centration of the pattern.Then, the mirrors were replaced, the resonator channels were checked and adjusted, the optics bench was inspected, the near and far alignments were checked and adjusted as needed, as well as the centration.Lastly, the interior and exterior were inspected for leaks and damages, and it was verified that all system circuits were working accordingly.After testing the device, it was found that the console had all qualities within specifications and ready to be used.A risk review performed, for the vpps series was completed."ineffective treatment which may require prolonged operation or re-operation" confirmed that the events of "device - low power" is a known event defined in the product risk management documentation.After the field service performed, when the optic relay and high reflector mirrors were replaced, the reported low power was resolved.The identified problem could have affected the device performance, which lead to the event experienced by the customer.The conclusion code cause traced to component failure is assigned to this investigation because it was determined that this event was an expected or random components problem without any design or manufacturing issue.
Event or Problem Description
It was reported that this device would not reach enough energy during a procedure.No further information has been reported.

• 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; hakidm st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20412276
• Report Number: 2124215-2024-62775
• Device Sequence Number: 8445266
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: 07290109146195
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/09/2024

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
• Device Lot Number: 002-43517
• 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: 09/18/2024
• Initial Report FDA Received Date: 10/09/2024
• 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