MAUDE Adverse Event Report: LUMENIS LTD LUMENIS SLIMLINE EZ SIS SINGLE USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-922
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the fiber was placed inside the opened ended ureteral catheter and being actively used when the laser fiber itself broke in two pieces outside the patient.A loud noise was audible in the room.The laser was turned off and the two pieces of the laser fiber were retrieved.The procedure was completed with another device.There was no patient complication.

• Brand Name: LUMENIS SLIMLINE EZ SIS SINGLE USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19489460
• Report Number: 2124215-2024-33831
• Device Sequence Number: 7089694
• Product Code: GEX
• UDI-Device Identifier: 17290109140213
• UDI-Public: 17290109140213
• Combination Product (Y/N): N
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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: 840-922
• Device Catalogue Number: 840-922
• Device Lot Number: 0098600722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Date Device Manufactured: 07/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown