MAUDE Adverse Event Report: LASER PERIPHERALS, LLC 8000231; POWERED LASER SURGICAL INSTRUMENT

Model Number	8000231
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device would not screw into machine.

• Brand Name: 8000231
• 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: 14884862
• Report Number: 14884862
• Device Sequence Number: 14790305
• Product Code: GEX
• UDI-Device Identifier: 00816469021346
• UDI-Public: (01)00816469021346(17)261111(10)DK21017
• 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): 06/13/2022
• Report Date (Section F): 06/21/2022

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: 8000231
• Device Catalogue Number: 8000231
• Device Lot Number: DK21017
• 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: 07/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2022
• 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: 06/21/2022