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

Model Number	SU-200-TRUE-RT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Physician performing ureteroscopy for left ureteral stone and using 272 holmium laser fiber.Mid procedure, surgeon noted laser tip no longer intact.The small, detached tip was briefly seen on the monitor, but with the water running, it was quickly out of sight.The broken tip was not recovered.Urocatch bag searched by rn and no tip visualized.The remaining long laser fiber was removed from the patient and isolated in its original packaging.A new laser fiber was opened, inspected, and used to perform the remaining procedure without complication.Md aware that original laser fiber tip was not recovered.No patient complication observed.

• Brand Name: SMARTSCOPE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): FORTEC FIBERS, INC.; 6245 hudson crossing pkwy; hudson OH 44236
• MDR Report Key: 15770326
• Report Number: 15770326
• Device Sequence Number: 5144646
• Product Code: GEX
• UDI-Device Identifier: 00816901020326
• UDI-Public: 00816901020326
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/25/2022
• Report Date (Section F): 10/25/2022

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: Health Professional
• Device Model Number: SU-200-TRUE-RT
• Device Catalogue Number: 096975
• Device Lot Number: M20013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2022
• 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: Male
• Date Report Sent to FDA: 10/25/2022