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	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A laser fiber wire broke off inside of the patient's right kidney.After speaking with the surgeon about it, he felt that no other intervention was necessary including an xray.He said the reason he felt an x-ray was unnecessary was because "laser fiber tips are non detectable through x-ray".Surgeon also stated that after looking in the patient's ureter and kidney that the fiber was undetectable and "did not see it in order to retrieve it".Upon further conversation, surgeon did state that he would "inform the patient of what happened" regarding the fiber wire tip.This is not the first time laser fiber wire tips of this particular brand and batch have broken off during surgical procedures.Tip of the fiber while it was inserted through the scope.Tip of the fiber broke while running up the scope.The fiber was still useable.Settings: energy: 0.3j, frequency: 50hz, power: 24w.

• Brand Name: 8000229
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LASER PERIPHERALS, LLC; 13355 10th avenue north; suite 110; plymouth MN 55441
• MDR Report Key: 22737162
• Report Number: 22737162
• Device Sequence Number: 7218177
• 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): 07/30/2025
• Report Date (Section F): 07/30/2025

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: DE25029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Date Report Sent to FDA: 07/30/2025