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	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Md noticed that the fiber wire was weak and was going to break if used.If the fiber wire had been used there was potential that the fiber could have broken off inside the patient.Md opened a new fiber wire to complete the procedure.

• Brand Name: 8000229
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LASER PERIPHERALS, LLC; 13355 10th ave north, suite 110; plymouth MN 55441
• MDR Report Key: 17142558
• Report Number: 17142558
• Device Sequence Number: 11229793
• 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): 05/31/2023
• Report Date (Section F): 06/01/2023

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: 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: 06/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2023
• 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: 06/01/2023