MAUDE Adverse Event Report: LASER PERIPHERALS, LLC 8000229; POWERED LASER SURGICAL INSTRUMENT

Model Number	8000229
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At 0840 it was time for laser lithotripsy and the laser rep, passed off the agiliti 272u laser fiber pl with lot# db25006.The laser fiber broke, two pieces broke off inside the patient, two broken pieces were retrieved and bagged.A second laser fiber, agiliti 272u laser fiber pl also with lot# db25006 was opened and passed to surgeon.The second laser fiber broke, one piece broke off in the patient, one piece was retrieved and bagged.A third laser fiber, agiliti 272u laser fiber pl with new lot# db25017 was opened and passed to surgeon.The third laser fiber broke, one piece broke off in the patient, one piece was retrieved and bagged.Laser services were discontinued.All fibers and broken pieces were bagged and labled.Surgeon requested different laser machine to be brought in.Stent was placed and patient procedure concluded.Agiliti laser rep, put in an incident report with his company which was to be sent to or manager.

• Brand Name: 8000229
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LASER PERIPHERALS, LLC; 13355 10th avenue north suite; plymouth MN 55441
• MDR Report Key: 21976055
• Report Number: 21976055
• Device Sequence Number: 18454795
• Product Code: GEX
• UDI-Device Identifier: 00816469021315
• UDI-Public: (01)00816469021315
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/23/2025
• Report Date (Section F): 04/23/2025

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: 8000229
• Device Catalogue Number: 8000229
• Device Lot Number: DB25006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 04/23/2025