FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 11MM DIAMETER - 100 MM LEN
MDR report key: 1081888
·
Received July 22, 2008
Report
- Report Number
- 3005075853-2008-00623
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 30, 2008
- Report Date
- June 30, 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
- IL, US
- 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 LAP CHOLE PROCEDURE, UPON REMOVAL OF ANY INSTRUMENT THROUGH THE TROCAR, THE IRIS VALVE SEAL WOULD LEAK. THERE WAS SOME LOSS OF PNEUMO. IT WAS NOT NECESSARY TO REPLACE THE TROCAR AS THE LEAK WOULD EVENTUALLY STOP. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 11MM DIAMETER - 100 MM LEN | GCJ | ETHICON ENDO-SURGERY, LLC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |