FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** XCEL* BLADELESS TROCAR
MDR report key: 3163185
·
Received June 11, 2013
Report
- Report Number
- 3005075853-2013-02933
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Date of Event
- May 13, 2013
- Report Date
- May 20, 2013
- 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
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC RESECTION PROCEDURE, THE TROCAR USED AS OPERATIVE ACCESS, WINDED (LEAKED) FROM THE ACCESSORY VALVE. THE SURGEON HAD TO PLUG THE ACCESS HOLE WITH THEIR FINGERS WHEN HE CHANGED OPERATIVE INSTRUMENT. NO PATIENT CONSEQUENCES REPORTED. DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264527 | ENDOPATH** XCEL* BLADELESS TROCAR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |