MAUDE Adverse Event Report: OPTICAL INTEGRITY INC 272 SMARTSCOPE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	FT-0272S-RT-00C-FOR-1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During left ureteroscopy procedure , laser was being used, surgeon notified staff that a small plastic piece had come off during procedure.Piece was retrieved c-arm was being used for procedure - no evidence of any retained pieces.

• Brand Name: 272 SMARTSCOPE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): OPTICAL INTEGRITY INC; 19408 panama city beach pkwy; panama city beach FL 32413
• MDR Report Key: 19351238
• Report Number: 19351238
• Device Sequence Number: 7109661
• Product Code: GEX
• UDI-Device Identifier: 00810077630648
• UDI-Public: (01)00810077630648
• 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): 02/20/2024
• Report Date (Section F): 02/20/2024

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: FT-0272S-RT-00C-FOR-1
• Device Catalogue Number: 11797
• Device Lot Number: M21661
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2024
• 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: 02/20/2024