FDA Adverse Event
Other
Summary report: N
MEDTRONIC BIOPSY NEEDLE, IG, 2.0MM
MDR report key: 954410
·
Received November 27, 2007
Report
- Report Number
- 1723170-2007-00010
- Event Type
- Other
- Date Received
- November 27, 2007
- Date of Event
- October 31, 2007
- Report Date
- November 27, 2007
- Manufacturer
- MEDTRONIC NAVIGATION, INC.
- Product Code
- KNW
- PMA / PMN Number
- K971247
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS NOT RETURNED PER PROCEDURES REGARDING USED, DISPOSABLE DEVICES. DEFORMATION OF OUTER CANNULA TIP WAS NOTICED DURING CASE BUT DID NOT AFFECT SUCCESSFUL COMPLETION OF PROCEDURE. CAUSE OF DEFORMATION NOT KNOWN AND REOCCURRENCE IS CONSIDERED EXTREMELY REMOTE. NO NEGATIVE IMPACT ON PT HEALTH.
Description of Event or Problem · 1
WHILE PERFORMING A NAVIGATED BIOPSY PROCEDURE, USING ACTIVE BIOPSY NEEDLE, THE SURGEON NOTCIED THAT THE TIP OF THE OUTER CASING (OUTER CANNULA) OF THE NEEDLE WAS BENT AND STARTED TO OPEN UP. TIP DID NOT BECOME DETACHED AND BIOPSY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC BIOPSY NEEDLE, IG, 2.0MM | ACTIVE BIOPSY NEEDLE | KNW | MEDTRONIC NAVIGATION, INC. | 960-225 | 18060913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |