FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR
MDR report key: 757854
·
Received October 25, 2005
Report
- Report Number
- 1527736-2005-05096
- Event Type
- Malfunction
- Date Received
- October 25, 2005
- Date of Event
- October 10, 2005
- Report Date
- October 10, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN LSO PROCEDURE, THE DEVICE CRACKED AT THE MOST DISTAL PORTION. A DEVICE OF A DIFFERENT PRODUCT CODE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLADELESS TROCAR | TROCAR | GCJ | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | A4AE6V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |