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

Model Number	8000229
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
One fiber broke and wore out faster than expected.Continued to open another fiber that worked correctly.

• 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: 16232205
• Report Number: 16232205
• Device Sequence Number: 6972857
• Product Code: GEX
• UDI-Device Identifier: 00816469021315
• UDI-Public: (01)00816469021315(17)270804(10)DG22048
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2023
• Report Date (Section F): 01/19/2023

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: Other
• Device Model Number: 8000229
• Device Catalogue Number: 8000229
• Device Lot Number: DG22048
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/19/2023