MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-18 for THE SPIDER * manufactured by Tenet Medical Engineering (distributed By Smith And Nephew).
[1571489]
During the procedure, the surgeon was manipulating the spider arm when it suddenly disengaged from the pt's arm, allowing the arm to drop and break sterile technique. This caused the arm to become unsterile in the sterile field. The arm was redraped and reattached to the spider arm, gloves were changed and the procedure continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1786486 |
| MDR Report Key | 1786486 |
| Date Received | 2010-07-18 |
| Date of Report | 2010-07-18 |
| Date of Event | 2010-06-01 |
| Report Date | 2010-07-18 |
| Date Reported to FDA | 2010-07-18 |
| Date Added to Maude | 2010-08-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE SPIDER |
| Generic Name | SPIDER ARM |
| Product Code | JEB |
| Date Received | 2010-07-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TENET MEDICAL ENGINEERING (DISTRIBUTED BY SMITH AND NEPHEW) |
| Manufacturer Address | 28403 NORTH 55TH ST CAVE CREEK AZ 85331 US 85331 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-18 |