FDA Adverse Event
Malfunction
Summary report: N
NEEDLE GUIDE
MDR report key: 19835190
·
Received July 26, 2024
Report
- Report Number
- 3023140882-2024-00005
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- July 11, 2024
- Report Date
- November 29, 2024
- Manufacturer
- QUANTUM SURGICAL SAS
- Product Code
- JAK
- UDI-DI
- 03760305400048
- PMA / PMN Number
- K223758
- Removal / Correction Number
- Z-0037-2025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE AFFECTED DEVICE HAS BEEN REPAIRED.
Description of Event or Problem · 0
DURING MAINTENANCE AT A CUSTOMER LOCATION, IT WAS NOTICED THAT FOR THE NEEDLE GUIDE 02-0027 0321015 THE AXIS MAINTAINING THE SPRING HAS OXIDATION ON THE TOP AND BOTTOM PART. THERE WAS NO PATIENT INVOLVED.
Description of Event or Problem · 0
DURING MAINTENANCE AT A CUSTOMER LOCATION, IT WAS NOTICED THAT FOR THE NEEDLE GUIDE 02-0027 0321015 THE AXIS MAINTAINING THE SPRING HAS OXIDATION ON THE TOP AND BOTTOM PART. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1734745 | NEEDLE GUIDE | NEEDLE GUIDE | JAK | QUANTUM SURGICAL SAS | 02-0027 | 03760305400048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |