FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDO-SURGERY INC.
MDR report key: 378933
·
Received February 20, 2002
Report
- Report Number
- 378933
- Event Type
- Malfunction
- Date Received
- February 20, 2002
- Date of Event
- February 1, 2002
- Report Date
- February 20, 2002
- Manufacturer
- ETHICON ENDOSURGERY
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ENDOPATH MULTISEAL CAP. THE INNER SEAL WAS FOUND IN THE ABDOMEN AND REMOVED LAPAROSCOPICALLY BY PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETHICON ENDO-SURGERY INC. | ENDOPATH MULTISEAL CAP REDUCTOUR | GCJ | ETHICON ENDOSURGERY | A 92205P00 | 2006-09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |