FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** XCEL* TROCAR
MDR report key: 2220415
·
Received August 23, 2011
Report
- Report Number
- 3005075853-2011-03464
- Event Type
- Malfunction
- Date Received
- August 23, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 4, 2011
- 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
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL GASTRECTOMY PROCEDURE, AIR LEAKED A LOT. THE AIR LEAK STARTED IN ABOUT 40 MINUTES. WHILE A FORCEPS WAS BEING INSERTED, AIR DID NOT LEAK. A BOO SOUND WAS HEARD FROM THE DEVICE. THE ABDOMINAL PRESSURE WAS 10MMHG AND HIGH FLOW. THE DEVICE WAS USED AS-IS TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH** XCEL* TROCAR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | H43T7H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | FORCEPS |