MAUDE Adverse Event Report: FORTEC FIBERS, INC.; POWERED LASER SURGICAL INSTRUMENT

Model Number	SU-365-RT
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Started to activate the laser and the cord sparked and shorted.Biomed and supervisor were called.Laser machine was switched out.Cased completed with new machine.

• Brand Name: NA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): FORTEC FIBERS, INC.; 10125 wellman rd; streetsboro OH 44241
• MDR Report Key: 7909412
• Report Number: 7909412
• Device Sequence Number: 19400481
• Product Code: GEX
• UDI-Device Identifier: 00816901020272
• UDI-Public: (01)00816901020272
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 09/20/2018
• Report Date (Section F): 09/20/2018

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: SU-365-RT
• Device Catalogue Number: 096875
• Device Lot Number: J46483
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/20/2018