FDA Adverse Event
Injury
Summary report: N
ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE -12 MM DIAMETER, 100 MM
MDR report key: 1053135
·
Received May 19, 2008
Report
- Report Number
- 1527736-2008-03158
- Event Type
- Injury
- Date Received
- May 19, 2008
- Date of Event
- April 25, 2008
- Report Date
- April 29, 2008
- 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
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SIGMOID PROCEDURE, CRACKED SLEEVE. SEVERAL PLASTIC FRAGMENTS OF THE SLEEVE FELL IN THE PT. THE SURGEON RECOVERED A FEW FRAGMENTS BUT IS NOT SURE IF ALL WERE REMOVED FROM THE PT. UNK HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE -12 MM DIAMETER, 100 MM | GCJ | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | E4KJ2E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |