FDA Adverse Event
Malfunction
Summary report: N
SPIDER - SINGLE PORT SURGICAL DEVICE
MDR report key: 1853687
·
Received September 8, 2010
Report
- Report Number
- 3007593944-2010-00014
- Event Type
- Malfunction
- Date Received
- September 8, 2010
- Date of Event
- August 12, 2010
- Report Date
- September 8, 2010
- Manufacturer
- TRANSENTERIX, INC.
- Product Code
- GCJ
- PMA / PMN Number
- K090902
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING A PATIENT LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE SURGEON NOTICED THAT THE LEFT IDT LINK ARM WAS NOT FUNCTIONING PROPERLY. A PIECE OF THE LINK ARM CONNECTOR FELL INTO THE SURGICAL BED AND WAS RECOVERED. NO INJURY OR IMPACT TO PATIENT CARE WAS REPORTED. THE DEVICE WAS NOT RETURNED TO TRANSENTERIX, INC. FOR EVALUATION. UNSURE IF ALL PIECES ACCOUNTED FOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDER - SINGLE PORT SURGICAL DEVICE | LAPAROSCOPIC, GENERAL & PLASTIC | GCJ | TRANSENTERIX, INC. | 9000020 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |