FDA Adverse Event
Malfunction
Summary report: N
SPIDER - SINGLE PORT SURGICAL DEVICE
MDR report key: 1927407
·
Received August 31, 2010
Report
- Report Number
- 3007593944-2010-00010
- 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
DURING A PT CHOLECYSTECTOMY PROCEDURE, THE SURGEON NOTICED THAT THE LEFT LOWER LINK ARM ON THE SPIDER WAS NOT FUNCTIONING PROPERLY. UPON REMOVAL, THE SURGEON NOTICED THAT A FRAGMENT OF THE PLASTIC INSERTION TUBE FITTING WAS MISSING. 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 | GCJ | TRANSENTERIX INC. | 9000020 | TRX086201001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |