MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-12-09 for SPIDER SURGICAL PLATFORM 9000020 G2 9000040 manufactured by Transenterix Inc..
[21752649]
According to the physician who reported the incident, the pt was not given enough anesthesia and the abdomen became tight, pushing the bowel forward. This occurred at the end of the laparoscopic surgical procedure when the surgeon was just starting to withdraw the spider device. Because the abdomen was then low, the tether wire dragged against the bowel causing a small tear in the bowel. The surgeon repaired the injury by stitching the bowel. The surgeon did not attribute the incident to the medical device.
Patient Sequence No: 1, Text Type: D, B5
[21901582]
The labeled instructions for the spider device clearly indicate to remove device before removing insufflation which is also standard laparoscopic technique. Lack of proper insufflation was the primary contributing factor in this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007593944-2011-00010 |
| MDR Report Key | 2372102 |
| Report Source | 05 |
| Date Received | 2011-12-09 |
| Date of Report | 2011-12-09 |
| Date of Event | 2011-11-04 |
| Date Mfgr Received | 2011-11-14 |
| Date Added to Maude | 2011-12-15 |
| 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 SUITE 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 | 2011-12-09 |
| Model Number | 9000020 G2 |
| Catalog Number | 9000040 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSENTERIX INC. |
| Manufacturer Address | DURHAM NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-09 |