MAUDE Adverse Event Report: QUANTA SYSTEM S.P.A. OAF FIBER; SURGICAL LASER FIBER

Model Number	OAF702711
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Optical fiber tip broken.No adverse effects to patient were reported.We are waiting for additional information from the distributor.
Event or Problem Description
Fiber tip broke inside the patient.No adverse effects to patient were reported.
Additional Manufacturer Narrative
Optical fiber tip broken: impossible to determine the root cause as returned not sterile.No adverse effects to patient were reported.
Event or Problem Description
Fiber tip broke inside the patient.No adverse effects to patient were reported.

• Brand Name: OAF FIBER
• Common Device Name: SURGICAL LASER 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: 11805686
• Report Number: 3004378299-2021-00073
• Device Sequence Number: 16418749
• Product Code: GEX
• UDI-Device Identifier: 08033945936723
• UDI-Public: 08033945936723
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: OAF702711
• Device Lot Number: A205120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/11/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2020
• 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