FDA Adverse Event
Malfunction
Summary report: N
NEEDLE GUIDE
MDR report key: 19730998
·
Received July 12, 2024
Report
- Report Number
- 3023140882-2024-00002
- Event Type
- Malfunction
- Date Received
- July 12, 2024
- Date of Event
- June 13, 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
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE AFFECTED DEVICE HAS BEEN REPAIRED.
Description of Event or Problem · 0
AT CUSTOMER LOCATION AFTER AN INTERVENTION, IT WAS OBSERVED ON THE NEEDLE GUIDE 02-0027 (B)(6), SOME RUST ON THE TOP OF THE CENTRAL AXIS. NO OTHER PARTS OR COMPONENTS OF THE NEEDLE GUIDE WERE CONCERNED BY CORRODED ISSUE. NO PATIENT HARM WAS REPORTED.
Description of Event or Problem · 0
AT CUSTOMER LOCATION AFTER AN INTERVENTION, IT WAS OBSERVED ON THE NEEDLE GUIDE 02-0027 0321020, SOME RUST ON THE TOP OF THE CENTRAL AXIS. NO OTHER PARTS OR COMPONENTS OF THE NEEDLE GUIDE WERE CONCERNED BY CORRODED ISSUE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2384624 | NEEDLE GUIDE | NEEDLE GUIDE | JAK | QUANTUM SURGICAL SAS | 02-0027 | 03760305400048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |