MAUDE Adverse Event Report: QUANTA SYSTEM SPA SINGLE USE SURGICAL OPTICAL FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	OFH302721
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Empower sterile surgical laser fiber broke in half where it entered the flexible ureteroscopy scope.After it broke it landed on the drape and burned a tiny hole in drape.No harm was caused to the patient.No harm was caused to any of the staff.Both pieces of the laser fiber were kept and turned in.Fiber will be returned by site staff for failure analysis.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): QUANTA SYSTEM SPA; 4545 n ocean blvd apt 11a; boca raton FL 33431
• MDR Report Key: 9636380
• Report Number: 9636380
• Device Sequence Number: 19529031
• Product Code: GEX
• UDI-Device Identifier: 08033945938284
• UDI-Public: (01)08033945938284
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/29/2019
• Report Date (Section F): 10/29/2019

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: No Information
• Device Model Number: OFH302721
• Device Catalogue Number: EMP-FBX200BHS-C
• Device Lot Number: H182820
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2020
• 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: 10/29/2019