FDA Adverse Event
Summary report: N
ENDOPATH XCEL
MDR report key: 3792036
·
Received April 17, 2014
Report
- Report Number
- 3792036
- Date Received
- April 17, 2014
- Date of Event
- February 8, 2014
- Report Date
- April 17, 2014
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- GCJ
- Report Source
- User Facility report
- Reporter Location
- WA, US
Narratives
Description of Event or Problem · 1
SEAL LEAKING CO2, OPENED NEW TO FINISH CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235508 | ENDOPATH XCEL | LAPAROSCOPE, UNIVERSAL TROCAR STABILITY SLEEVE | GCJ | ETHICON ENDO-SURGERY | * | L4E10U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |