MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-11 for * ET0858F NOT REPORTED manufactured by Sri/surgical Express, Inc..
[20349613]
An irrigating bipolar cord from the harvest set would not plug into the unit. The cord plug just kept falling out of the holes, despite being inserted all the way. Another cord was added. It fit into the socket, but not tightly. The fit was adequate to hold the plugs in place without intervention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 593252 |
| MDR Report Key | 593252 |
| Date Received | 2005-04-11 |
| Date of Report | 2005-04-11 |
| Date of Event | 2005-02-24 |
| Report Date | 2005-04-11 |
| Date Reported to FDA | 2005-04-11 |
| Date Added to Maude | 2005-04-21 |
| 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 | 3 |
| 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 | * |
| Generic Name | IRRIGATING BIPOLAR CORD |
| Product Code | FFZ |
| Date Received | 2005-04-11 |
| Model Number | ET0858F |
| Catalog Number | NOT REPORTED |
| Lot Number | NOT REPORTED |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 583097 |
| Manufacturer | SRI/SURGICAL EXPRESS, INC. |
| Manufacturer Address | 12425 RACE TRACK RD TAMPA FL 33626 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-04-11 |