FDA Adverse Event
Summary report: N
12X100MM KII FIOS FIRST ENTRY THREADED 6/BOX
MDR report key: 2112426
·
Received March 15, 2011
Report
- Report Number
- 2027111-2011-00030
- Date Received
- March 15, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 15, 2011
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN. FOLLOW UP WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
ROBOTIC PROSTATECTOMY - "12X150 TROCAR CRACKED WAS FOUND TO HAVE A PIECE MISSING PART WAS THROUGH CASE. DR. (B)(6) AWARE & EST MISSING PIECE TO BE 2-3MM IN DIAMETER. SURGERY COMPLETED UNEVENTFULLY & TROCAR FOUND TO BE BROKEN. TRY TO WRAP PETROLEUM GAUZE AROUND HOLE IN TROCAR TO PREVENT PRESSURE LOSS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X100MM KII FIOS FIRST ENTRY THREADED 6/BOX | NONE | GCJ | APPLIED MEDICAL | CFI83 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |