FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES
MDR report key: 1150960
·
Received August 28, 2008
Report
- Report Number
- 3005075853-2008-01421
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GCJ
- PMA / PMN Number
- K070198
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY PROCEDURE, THE DEVICE TORE AROUND THE RIM. THIS HAPPENED AT THE BEGINNING OF THE PROCEDURE. HE USED A SECOND DEVICE TO COMPLETE THE CASE WITH NO ADVERSE PATIENT OUTCOMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES | GCJ | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |