MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. OPTICAL FIBER

Model Number	OAF009911
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Optical fiber broke inside the resectoscope.We are unaware about operator/patient injury.We are waiting for additional information from the distributor.
Event or Problem Description
The optical fiber had a failure that did not allow to use it.No adverse effects to patient were reported.

• Brand Name: OPTICAL FIBER
• Common Device Name: OPTICAL FIBER
• Manufacturer (Section D): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer (Section G): QUANTA SYSTEM S.P.A.; via acquedotto, 109; samarate, 21017 ; IT 21017
• Manufacturer Contact: dario bandiera ; via acquedotto, 109; samarate, varese 21017 ; IT 21017
• MDR Report Key: 13512204
• Report Number: 3004378299-2022-00005
• Device Sequence Number: 5299170
• Product Code: GEX
• UDI-Device Identifier: 08033945933548
• UDI-Public: 08033945933548
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K131473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Inspection,Replace
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

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
• Device Model Number: OAF009911
• Device Catalogue Number: OAF009911
• Device Lot Number: A211402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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