FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-15MM
MDR report key: 1083035
·
Received July 23, 2008
Report
- Report Number
- 3005075853-2008-00636
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 26, 2008
- Report Date
- June 27, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC BANDING PROCEDURE, THE "DUCT BILE" ON THE TROCAR WAS DEFORMED. AIR WAS LEAKING FROM THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-15MM | NONE | GCJ | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |