FDA Adverse Event
Other
Summary report: N
ONCOSMART PROGUIDE NEEDLE
MDR report key: 2911041
·
Received January 9, 2013
Report
- Report Number
- 9611894-2012-00008
- Event Type
- Other
- Date Received
- January 9, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 7, 2013
- Manufacturer
- NUCLETRON
- Product Code
- JAQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY INDICATED THAT THERE WERE NO PT EFFECTS RESULTING FROM THE EMBEDDED FRAGMENT. THE INVESTIGATION INTO THIS EVENT IS ONGOING AT THIS TIME. ONCE THE INVESTIGATION IS COMPLETE, ELEKTA WILL FORWARD ADDITIONAL INFORMATION TO THE FDA.
Description of Event or Problem · 1
THE TIP OF A PROGUIDE NEEDLE BROKE-OFF. THE BROKEN PROGUIDE WAS DISCOVERED AFTER CT SCANNING WHEN MEASURING THE REFERENCE DISTANCE BEFORE TREATMENT PLANNING. THE NEEDLE WAS REMOVED AND THE BROKEN FRAGMENT OF THE PROGUIDE NEEDLE REMAINED IN THE PT. THE FACILITY INDICATED THAT THERE WERE NO PT EFFECT RESULTING FROM THE EMBEDDED FRAGMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11924 | ONCOSMART PROGUIDE NEEDLE | JAQ, HDR REMOTE AFTERLOADER ACCESSORY | JAQ | NUCLETRON |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |