MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-08 for SPIDER SURGICAL PLATFORM 9000020 G2L 9000041 manufactured by Transenterix Inc..
[18277940]
During a laparoscopic procedure, the surgeon reported a loss of responsiveness with the device due to a loose wire. The unit was returned 30 days after the event was reported and during the evaluation of the unit, it was determined that the wire had broken. No injury or impact to patient care was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007593944-2012-00005 |
| MDR Report Key | 2613392 |
| Report Source | 05 |
| Date Received | 2012-06-08 |
| Date of Report | 2012-06-08 |
| Date of Event | 2012-04-07 |
| Date Mfgr Received | 2012-05-07 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS TAMMY CARREA, VP |
| Manufacturer Street | 635 DAVIS DRIVE STE 300 |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9197658420 |
| Manufacturer Street | 2933 SOUTH MIAMI STE 119 |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27703 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIDER SURGICAL PLATFORM |
| Generic Name | OTJ, LAPAROSCOPIC SINGLE PORT ACCESS |
| Product Code | OTJ |
| Date Received | 2012-06-08 |
| Returned To Mfg | 2012-05-07 |
| Model Number | 9000020 G2L |
| Catalog Number | 9000041 |
| Lot Number | TX017121 |
| ID Number | NA |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSENTERIX INC. |
| Manufacturer Address | DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-06-08 |