FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE PROXIMATE PLUS MD SKIN STAPLER
MDR report key: 182310
·
Received August 12, 1998
Report
- Report Number
- 1527736-1998-02432
- Event Type
- Malfunction
- Date Received
- August 12, 1998
- Report Date
- April 9, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC., S.A DE C.V
- Product Code
- GDT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY A MATERIAL MRG THE DEVICE WAS USED IN AN UNK PROCEDURE. IT WAS REPORTED THE DOCTOR FEELS HE CAN'T SEE WHERE HE IS STAPLING WITH THIS NEW STAPLER, AND FEELS IT DOESN'T FIRE PROPERLY. THE DEVICE WAS DISCARDED. THERE WAS NO CONSEQUENCE TO THE PT. THE REP WAS NOTIFIED TO FOLLOW UP. 04/16/1998 THE REP REPORTS THE STAPLES WERE NOT FORMING COMPLETELY AND ROLLING IN THE WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PROXIMATE PLUS MD SKIN STAPLER | SKIN STAPLERS | GDT | ETHICON ENDO-SURGERY, INC., S.A DE C.V | NA | L49A62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |