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

Model Number	0638-803-01
Medical Device Problem Codes	Failure to Power Up (1476); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a bladder stone procedure, the console shut down completely.It was restarted, turned key switch and makes sounds like it wants to power on but won not.Patient was stable under general anesthesia, there was no patient complication.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• 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: 18461583
• Report Number: 2124215-2024-00516
• Device Sequence Number: 7079658
• Product Code: GEX
• UDI-Device Identifier: 07290109146195
• UDI-Public: 07290109146195
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/07/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown