MAUDE Adverse Event Report: LUMENIS LTD VERSACUT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	0637-245-01
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the device was inserted into the patient bladder, the physician realized that versacut device was not working.The procedure was not completed due to this event.No patient complications reported.After that, it was notified by additional information that a replacement unit was sent due to the unit is under warranty.This event is being reported for a cancelled/rescheduled procedure with a patient under anesthesia or sedation status unknown.

• Brand Name: VERSACUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 16957580
• Report Number: 2124215-2023-23811
• Device Sequence Number: 6296589
• Product Code: GCJ
• UDI-Device Identifier: 07290109140681
• UDI-Public: 07290109140681
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 05/18/2023

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: 0637-245-01
• Device Catalogue Number: 0637-245-01
• Device Lot Number: 0000001922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown