FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM LE
MDR report key: 1150964
·
Received August 28, 2008
Report
- Report Number
- 3005075853-2008-01426
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 14, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CHOLECYSTECTOMY PROCEDURE, AN AIR LEAK OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM LE | GCJ | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |