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

Model Number	DB-400
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The pt was having a surgical procedure done when part of the laser fiber broke off of the instrument.The surgeon was able to retrieve all parts and no harm was noted to the pt.Fda safety report id# (b)(4).

• Brand Name: LASER PERIPHERALS SURGICAL FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LASER PERIPHERALS LLC; plymouth MN 55441
• MDR Report Key: 9244812
• Report Number: MW5090692
• Device Sequence Number: 2599763
• Product Code: GEX
• UDI-Device Identifier: 00816469020004
• UDI-Public: (01)00816469020004
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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 Expiration Date: 08/01/2024
• Device Model Number: DB-400
• Device Catalogue Number: DB-400
• Device Lot Number: DG19091
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1