FDA Adverse Event
Malfunction
Summary report: N
PROSTIVA
MDR report key: 2945901
·
Received February 6, 2013
Report
- Report Number
- 3007566237-2013-00386
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 10, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- KNS
- PMA / PMN Number
- K052413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS OF THE DEVICE DETERMINED THE SHEATH FAILED TO RETRACT. ACTUATION RODS BECAME DETACHED FROM THE SHEATH. HANDPIECE WITH RETRACTABLE NEEDLE.
Description of Event or Problem · 1
IT WAS REPORTED THE THERE WAS A FAILURE TO EXTRACT THE NEEDLES WITH THE DEVICE, ALSO STATED AS A FAILURE TO RETRACT. THE PHYSICIAN EXTENDED THE NEEDLE LENGTH IN ORDER TO MAKE THE NEEDLES MORE FLEXIBLE BEFORE REMOVING THE HAND PIECE FROM THE PATIENT. IT WAS NOTED THAT AFTER REMOVAL THE TEFLON SHIELDING ON THE NEEDLES HAD SEPARATED. IT WAS REPORTED THIS OCCURRENCE WAS THE 2ND TIME THIS HAD HAPPENED; IT WAS UNCLEAR IF BOTH OCCURRENCES WERE RESOLVED IN THE SAME MANNER. REFER TO MANUFACTURER REPORT # 3007566237-2013-00385 FOR FIRST OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51060 | PROSTIVA | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | MEDTRONIC NEUROMODULATION | 8929 | 128489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |