FDA Adverse Event
Malfunction
Summary report: N
PROSTIVA
MDR report key: 1172907
·
Received September 19, 2008
Report
- Report Number
- 6000153-2008-05964
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 18, 2008
- Manufacturer
- MPROC, VILLALBA
- Product Code
- KNS
- PMA / PMN Number
- K052413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL DEVICE ANALYSIS REVEALED A RELIABILITY NON-CONFORMANCE. THE POSTS ON THE NEEDLE BLOCKS BROKE OFF. THERE APPEARED TO BE EXCESS EPOXY ON THE ACTIVATION RODS, NEEDLES, AND SCOPE TUBE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TRANSURETHRAL NEEDLE ABLATION OF THE PROSTATE PROCEDURE, THE NEEDLES WOULD NOT DEPLOY. SEVERAL NEEDLE LENGTHS WERE SELECTED AND NONE WOULD DEPLOY AFTER THE HANDLE WAS SQUEEZED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. NO INJURY TO THE PT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTIVA | KNS | MPROC, VILLALBA | 8929 | V056655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |