FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLUNT TIP TROCAR
MDR report key: 1191063
·
Received October 9, 2008
Report
- Report Number
- 1527736-2008-03587
- Event Type
- Malfunction
- Date Received
- October 9, 2008
- Date of Event
- May 22, 2008
- Report Date
- May 22, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 05/10/2008. INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP SPLENECTOMY PROCEDURE, THE TROCAR LEAKED. THE PROCEDURE WAS COMPLETED WITH NO PT CONSEQUENCE. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLUNT TIP TROCAR | NONE | GCJ | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4GL95 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |