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

Model Number	0638-804-01
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional email address: (b)(6).
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate procedure, the console displayed a low power message error and the procedure was rescheduled.During an inspection, it was found that the hr and oc mirrors are damaged.Then, the mirrors were replaced, and the system worked normally.There were no patient complications.This event is being reported for a rescheduled procedure with a patient under anesthesia or sedation status is unknown.
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code cause not established was assigned to this investigation.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question due to the patient was not sedated when the procedure was cancelled.H3 other text : the device did not return to bsc for analysis.
Event or Problem Description
It was reported that during a holmium laser enucleation of the prostate procedure, the console displayed a low power message error and during an inspection, it was found that the hr and oc mirrors are damaged.Then, the mirrors were replaced, and the system worked normally.There were no patient complications.This event is being reported for a rescheduled procedure with a patient under anesthesia.Additional information was received indicating that the patient was not under sedation when the procedure was cancelled.

• 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.; hakidma st 6; yokneam 20692 04; IS 2069204
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17139503
• Report Number: 2124215-2023-29186
• Device Sequence Number: 3941830
• Product Code: GEX
• UDI-Device Identifier: 07290109146218
• UDI-Public: 07290109146218
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2023

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
• Device Lot Number: 0000001145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown