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

Model Number	840-925
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy procedure for kidney stones, the fiber snapped in half inside the patient.Due to this, the procedure was completed using an alternate fiber.There were no patient complications.
Event or Problem Description
It was reported that during a percutaneous nephrolithotomy procedure for kidney stones, the fiber snapped in half inside the patient.Due to this, the procedure was completed using an alternate fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.Visual examination of the fiber tip identified the fiber was broken in two pieces.The microscopic analysis confirmed the fiber tip degraded, and the fiber connector did not present defects or damage, a bright and round light exiting the face.It is likely that procedural handling and procedural conditions of the device during set-up, use or reprocessing contributed to the fiber body break., leading to the reported event.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.Correction to fields g1 manufacturing site: mfr site facility name, mfr site address 1, mfr site city, mfr site state, mfr site zip/post code, mfr site country updated.

• Brand Name: LUMENIS SLIMLINE SIS REUSABLE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS LTD; hakidma 6; yokneam 20692 04; IS 2069204
• Manufacturer (Section G): LUMENIS; 2077 gateway place suite 300; san jose CA 95110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19197444
• Report Number: 2124215-2024-25226
• Device Sequence Number: 8305506
• Product Code: GEX
• UDI-Device Identifier: 07290109140247
• UDI-Public: 07290109140247
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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 Expiration Date: 10/20/2025
• Device Model Number: 840-925
• Device Catalogue Number: 840-925
• Device Lot Number: 0067731120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2020
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown