FDA Adverse Event
Malfunction
Summary report: N
SPIDER - SINGLE PORT SURGICAL DEVICE
MDR report key: 1853996
·
Received August 31, 2010
Report
- Report Number
- 3007593944-2010-00009
- Event Type
- Malfunction
- Date Received
- August 31, 2010
- Date of Event
- July 21, 2010
- Report Date
- August 31, 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
FOLLOWING THE END OF A MINIMALLY INVASIVE ABDOMINAL LAPAROSCOPIC PROCEDURE, THE SURGEON NOTICED THAT AT A SLIVER FROM THE LINK ARM CONNECTOR WAS LOCATED AT THE PT'S INCISION SITE. THE SURGEON CONFIRMED THAT THE PIECE FIT PERFECTLY WITH THE REST OF THE LINK ARM CONNECTOR AND THAT NO FRAGMENT FROM THE LINK ARM WAS LEFT IN THE PT. NO INJURY OR IMPACT OR PT CARE WAS REPORTED. THE DEVICE WAS 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 | TRX085201001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |