FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 75 MM LEN
MDR report key: 1121946
·
Received August 13, 2008
Report
- Report Number
- 3005075853-2008-01183
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- July 30, 2008
- Report Date
- July 31, 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
D4; H4, 6: INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, AN AIR LEAK OCCURRED 15 MINUTES AFTER THE TROCAR WAS INSERTED. WHEN THE REDUCER SEAL WAS REPLACED, THE AIR LEAK WAS STOPPED, AND THEN THE OPERATION WAS CONTINUED. 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, 75 MM LEN | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | E4LA2G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |