FDA Adverse Event
Injury
Summary report: N
VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV
MDR report key: 3800237
·
Received April 30, 2014
Report
- Report Number
- 9612501-2014-00134
- Event Type
- Injury
- Date Received
- April 30, 2014
- Date of Event
- April 15, 2014
- Report Date
- April 15, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GCJ
- PMA / PMN Number
- K954108
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: A PIECE OF THE TROCAR BROKE OFF IN THE PATIENT AND WAS NOT RECOVERED. AN XRAY WAS PERFORMED AND THERE WAS NOTHING THAT WAS SHOWN IN THE XRAY. THERE WAS NO TISSUE DAMAGE. THERE WAS NO UNANTICIPATED TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258670 | VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | COVIDIEN | J4A0340X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |