FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL
MDR report key: 3253854
·
Received July 25, 2013
Report
- Report Number
- 3253854
- Event Type
- Malfunction
- Date Received
- July 25, 2013
- Date of Event
- June 27, 2013
- Report Date
- July 25, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
Description of Event or Problem · 1
PATIENT WAS UNDERGOING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE. AFTER ABDOMINAL DISTENSION, THE NEEDLE WAS REMOVED AND THE 12 MM BLADELESS OPTICAL VIEWING TROCAR WAS INSERTED USING THE 5 MM LAPAROSCOPE TO VISUALIZE ENTRY. IT WAS NOTED THAT THE TROCAR TIP WAS INDENTED AND IRREGULAR. TROCAR WAS REMOVED AND REPLACED. NO INJURY WAS NOTED AS A RESULT OF THE DEFECTIVE TIP.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC LEFT SALPINGECTOMY, RIGHT NEOSALPINGOSTOMY, CHROMOTUBATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347664 | ENDOPATH XCEL | TROCAR, LAPAROSCOPIC | GCJ | ETHICON ENDO-SURGERY, INC. | B12XT | * | |
| 347687 | * | --- |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |