FDA Adverse Event
Malfunction
Summary report: N
SPIDER - SINGLE PORT SURGICAL DEVICE
MDR report key: 1903551
·
Received August 31, 2010
Report
- Report Number
- 3007593944-2010-00011
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- July 29, 2010
- Report Date
- August 13, 2010
- Manufacturer
- TRANSENTERIX, INC.
- Product Code
- GCJ
- PMA / PMN Number
- K090902
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING A MINIMALLY INVASIVE ABDOMINAL LAPAROSCOPIC PROCEDURE, THE SURGEON NOTICED THAT THE LEFT IDT WAS NOT FUNCTIONING PROPERLY. A SMALL PIECE OF THE LINK ARM CONNECTOR FELL INTO THE SURGICAL BED. THE SURGEON WAS ABLE TO LOCATE AND RETRIEVE THE PIECE FROM THE PT. NO INJURY OR IMPACT TO PT CARE WAS REPORTED. THE DEVICE WAS NOT RETURNED TO TRANSENTERIX, INC. FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDER - SINGLE PORT SURGICAL DEVICE | LAPAROSCOPIC, GENERAL & PLASTIC | GCJ | TRANSENTERIX, INC. | 9000020 | TRX169201002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |