FDA Adverse Event
Malfunction
Summary report: N
PROSTIVA
MDR report key: 1885216
·
Received October 25, 2010
Report
- Report Number
- 6000153-2010-08370
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- June 18, 2010
- Report Date
- September 28, 2010
- Manufacturer
- MPROC, VILLALBA
- Product Code
- KNS
- PMA / PMN Number
- K052413
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS OF THE DEVICE (MODEL: 8929, SN#: (B)(4)) REVEALED AN OPEN LEFT NEEDLE THERMOCOUPLE. OHMS FROM P1 TO P4 BOARD WERE TESTED AND HAD CONTINUITY. THE CIRCUIT WAS OPEN INSIDE THE NEEDLE. A HARDWARE ERROR CODE 66 WAS NOTED IN REGARDS TO A PROSTIVA 8929-EPROM DATA TEST.
Description of Event or Problem · 1
A DEVICE ISSUE OCCURRED PRIOR TO THE START OF A MEDICAL PROCEDURE. THE ISSUE WAS IN REGARDS TO AN ERROR CODE NUMBER 17. A SIZE 12 NEEDLE WAS NOTED. AN ALTERNATE HANDPIECE HAD TO BE USED TO COMPLETE THE PROCEDURE. THE PT'S OUTCOME WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTIVA | KNS | MPROC, VILLALBA | 8929 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| MODEL 8930, LOT# MGU0606041| ENDOSCOPIC ELECTROSURGICAL UNIT |