FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE- 12 MM DIAMETER, 100 MM LEN
MDR report key: 1080003
·
Received July 17, 2008
Report
- Report Number
- 3005075853-2008-00546
- Event Type
- Malfunction
- Date Received
- July 17, 2008
- Date of Event
- June 24, 2008
- Report Date
- June 25, 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 LADG PROCEDURE, THERE WERE TWO FALLING OBJECTS IN THE PATIENT'S ABDOMINAL CAVITY. THE TWO OBJECTS WERE REMOVED. THEY WERE CLEAR FILMS. THE SIZES WERE ABOUT 3MM BY 10MM. ALL TROCARS WERE REPLACED WITH NEW DEVICES 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 LEN | GCJ | ETHICON ENDO-SURGERY, LLC | NA | E4L018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |