FDA Adverse Event
Other
Summary report: N
PERCUNAV SYSTEM
MDR report key: 2170167
·
Received June 24, 2011
Report
- Report Number
- 3006377159-2011-00005
- Event Type
- Other
- Date Received
- June 24, 2011
- Report Date
- May 26, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IYO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHILIPS HEALTHCARE HAS BEEN INFORMED BY A SUPPLIER THAT CERTAIN PERCUNAV TOOL CONNECTION UNITS MAY CONTAIN AN ELECTRONIC COMPONENT THAT DOES NOT MEET SPECIFICATION, WHICH COULD CAUSE REGISTRATION DIFFICULTIES AND/OR INACCURATE INSTRUMENT TRACKING. A FIELD CORRECTION WAS REPORTED TO FDA ON JUNE 1, 2011 PER 3006377159-06-01-11-002-C.
Description of Event or Problem · 1
A PHILIPS SALES DEVELOPMENT MGR. REPORTED AN INCIDENT INVOLVING THE INABILITY OF THE PERCUNAV IMAGE GUIDED DEMO SYSTEM TO REGISTER TARGET LESION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERCUNAV SYSTEM | IYO IYN ITX | IYO | PHILIPS HEALTHCARE | 795084 | B00P3Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |