FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM LE
MDR report key: 1163335
·
Received September 10, 2008
Report
- Report Number
- 3005075853-2008-01626
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- May 22, 2008
- Report Date
- September 2, 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
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP HERNIA PROCEDURE, THE HISSING NOISE WHILE THE INSTRUMENT WAS EXCHANGED FROM THE FLAPPER VALVE. PNEUMO LOSS DISRUPTED THE ENTIRE PROCEDURE. UNKNOWN HOW CASE WAS COMPLETED. 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 |