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

Model Number	OFH302721
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During laser lithotripsy the empower laser fiber wire snapped.It broke at the entry point of the flexible ureteroscope.Another fiber wire was supplied and the exact event happened at the same point of entry.It was noticed that both fiber wires were the same reference and lot number.A third laser fiber wire was supplied that was the same 200 series but a different reference and lot number.It did not snap though it was noticed that the fiber wire was not lighting up with the green beam at the end of the fiber as it should.Charge rn notified that all 200 series wires will be gone through and any with the same reference and lot number as the defective fibers and will be placed in material bin with a note as to why.The effected wires from this event were sent to clinical engineering and examined under a microscope.The laser fibers will be returned to the manufacturer.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): QUANTA SYSTEM SPA; via acquedotto, 109; samarate varese 21017
• MDR Report Key: 9659279
• Report Number: 9659279
• Device Sequence Number: 3475199
• 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): 12/05/2019
• Report Date (Section F): 12/05/2019

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 Model Number: OFH302721
• Device Catalogue Number: EMP-FBX200BHS-C
• Device Lot Number: H183206
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2020
• 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: 12/05/2019