FDA Adverse Event
Malfunction
Summary report: N
SHORT 5MM CANNULA/DILATOR W/RAD ECPD SLV
MDR report key: 602282
·
Received July 1, 2004
Report
- Report Number
- 2647580-2004-00157
- Event Type
- Malfunction
- Date Received
- July 1, 2004
- Report Date
- June 2, 2004
- Manufacturer
- PONCE - USS
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, THE ETHICON RBI NEEDLESS WERE STICKING INSIDE THE CANNULAS. WHEN THIS OCCURRED THE TROCARS HAD TO BE REMOVED BECAUSE THE NEEDLES COULD NOT NOT BE PULLED OUT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHORT 5MM CANNULA/DILATOR W/RAD ECPD SLV | TROCAR | GCJ | PONCE - USS | NA | P4A1069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |