MAUDE Adverse Event Report: LUMENIS LTD SLIMLINE SIS; POWERED LASER SURGICAL INSTRUMENT

Model Number	0644-010-01
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a ureteroscopy procedure for urinary stone removal, the fiber made a popping sound, and it broke at initial firing.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Correction made to d3 manufacture name, manufacture address, manufacturer city, manufacturer zip/postal code, manufacturer country, manufacturer email, g1 mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip, mfr site country, mfr site phone, h6 evaluation conclusion code initially, this event was reported for the reported fiber break at the initial firing.However, additional information was received from the customer via good faith effort stating that the fiber did not present a physical break.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that during a ureteroscopy procedure for urinary stone removal, the fiber made a popping sound and did not work.The procedure was completed with another device.There were no patient complications.
Event or Problem Description
It was reported that during a ureteroscopy procedure for urinary stone removal, the fiber made a popping sound and did not work.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
Initially, this event was reported for the reported fiber break at the initial firing.However, additional information was received from the customer via good faith effort stating that the fiber did not present a physical break.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.

• Brand Name: SLIMLINE SIS
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma st 6; hakidma 6; yokneam AZ 20692 04; IS 2069204
• Manufacturer (Section G): MOLEX LLC; 18019 n 25th ave; phoenix AZ 85023
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17686299
• Report Number: 2124215-2023-47838
• Device Sequence Number: 2558694
• Product Code: GEX
• UDI-Device Identifier: 07290109140223
• UDI-Public: 07290109140223
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100228
• 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,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 0644-010-01
• Device Catalogue Number: 0644-010-01
• Device Lot Number: 0014840323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/08/2023; 09/21/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/22/2023; 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown