FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DEXTRUS SEAL CAP ASSEMBLY WITH ACCESSORIES
MDR report key: 1170359
·
Received September 12, 2008
Report
- Report Number
- 3005075853-2008-01676
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 21, 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
- AZ, 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 HAND ASSISTED NEPHRECTOMY PROCEDURE, THE SEAL CAP RIPPED IN THE BEGINNING OF THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
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 | E4L307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |