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

Model Number OAF002011

Device Problem Fracture (1260)

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

Event Date 02/02/2022

Event Type  malfunction  

Event Description

The optical fiber had a failure that did not allow to use it properly.No adverse effects to patient were reported.

Manufacturer Narrative

The problem could be traced to optical fiber failure.We are unaware of patient involvement.

• Brand Name: SINGLE USE SURGICAL OPTICAL FIBER
• Type of Device: SURGICAL 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: 13658165
• MDR Text Key: 287578840
• Report Number: 3004378299-2022-00024
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/03/2022

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: OAF002011
• Device Lot Number: A213222
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1