FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5 MM DIAMETER - 100 MM LEN
MDR report key: 1070573
·
Received July 2, 2008
Report
- Report Number
- 3005075853-2008-00269
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 11, 2008
- Report Date
- June 11, 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D4; H4, 6: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CANNULA OF THE DEVICE BROKE IN HALF. NO PIECES FELL INTO THE PT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE, 5 MM DIAMETER - 100 MM LEN | GCJ | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |