FDA Adverse Event
Malfunction
Summary report: N
SPIDER - SINGLE PORT SURGICAL DEVICE
MDR report key: 1814747
·
Received August 13, 2010
Report
- Report Number
- 3007593944-2010-00008
- Event Type
- Malfunction
- Date Received
- August 13, 2010
- Date of Event
- July 15, 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 PATIENT CHOLECYSTECTOMY PROCEDURE, THE SURGEON INSERTED, THROUGH THE SAME INCISION CUT AS THE SPIDER DEVICE, A RIGID SUCTION/IRRIGATION INSTRUMENT. THE SURGEON ACCIDENTALLY TANGLED THE SUCTION/IRRIGATION INSTRUMENT INTO THE SPIDER DEVICE AND BROKE OR SNAPPED LOOSE THE UPPER RIGHT LINK ARM AT THE LINK ARM CONNECTOR. A PIECE OF THE LINK ARM CONNECTOR FELL INTO THE SURGICAL BED. THE SURGEON WAS ABLE TO LOCATE AND RETRIEVE THE PIECE FROM THE PATIENT. NO INJURY OR IMPACT TO PATIENT CARE WAS REPORTED. THE DEVICE WAS RETURNED TO TRANSENTERIX, INC. FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDER - SINGLE PORT SURGICAL DEVICE | LAPAROSCOPIC, GENERAL & PLASTIC SURGERY | GCJ | TRANSENTERIX INC. | 9000020 | TRX086201002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |