MAUDE Adverse Event Report: QUANTA SYSTEM SPA SINGLE USE SURGICAL OPTICAL FIBER 200¿M; POWERED LASER SURGICAL INSTRUMENT

Model Number	OAF002011
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Malfunctioned while testing-- did not reach patient.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER 200¿M
• 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: 16416472
• Report Number: 16416472
• Device Sequence Number: 3327136
• Product Code: GEX
• UDI-Device Identifier: 08033945933487
• UDI-Public: 08033945933487
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/09/2023
• Report Date (Section F): 02/09/2023

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: OAF002011
• Device Catalogue Number: 220419
• Device Lot Number: A221704
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White
• Date Report Sent to FDA: 02/09/2023