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

Model Number OAF002011

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2023

Event Type  malfunction  

Event Description

Malfunctioned while testing-- did not reach patient.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER 200¿M
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): QUANTA SYSTEM SPA; 4545 n ocean blvd apt 11a; boca raton FL 33431
• MDR Report Key: 16416472
• MDR Text Key: 309957270
• Report Number: 16416472
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08033945933487
• UDI-Public: 08033945933487
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• 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
• Date Report Sent to FDA: 02/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Race: White