FDA Adverse Event
Injury
Summary report: N
ENDOPATH* XCEL TROCAR
MDR report key: 2250592
·
Received September 16, 2011
Report
- Report Number
- 1527736-2011-00155
- Event Type
- Injury
- Date Received
- September 16, 2011
- Date of Event
- March 31, 2011
- Report Date
- August 31, 2011
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED FROM CUSTOMER FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH* XCEL TROCAR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |