FDA Adverse Event
Malfunction
Summary report: N
LAP DISC HAND ACCESS DEVICE
MDR report key: 773686
·
Received August 21, 2006
Report
- Report Number
- 1527736-2006-03948
- Event Type
- Malfunction
- Date Received
- August 21, 2006
- Date of Event
- July 27, 2006
- Report Date
- July 28, 2006
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- k010870
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SECOND LOT NUMBER PROVIDED: 060201.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HAND ASSISTED COLON PROCEDURE, THREE DISCS TORE IN TWO DIFFERENT PLACES AROUND THE RING. WHEN THE THIRD ONE FAILED, THE PROCEDURE WAS ALMOST COMPLETED, SO THERE WAS NO NEED TO OPEN ANOTHER ONE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAP DISC HAND ACCESS DEVICE | GCJ | GCJ | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | 060323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |