MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-11-17 for ENTREE II VALVE/REDUCER CD775 manufactured by Core Dynamics.
[350976]
"during an endo-gi procedure, the seal fell out of the reducer and fell into the surgical field. It was retrieved and there was no patient injury or alternation of the procedure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-2003-00065 |
| MDR Report Key | 496648 |
| Report Source | 05,06 |
| Date Received | 2003-11-17 |
| Date of Report | 2003-10-17 |
| Date of Event | 2003-10-01 |
| Date Mfgr Received | 2003-10-17 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2003-11-21 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CRISINO |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243078 |
| Manufacturer G1 | CORE DYNAMICS |
| Manufacturer Street | 11222 ST. JOHN'S INDUS PKWY N |
| Manufacturer City | JACKSONVILLE FL 32246667 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32246 6675 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTREE II VALVE/REDUCER |
| Generic Name | ENDO VALVE/REDUCER |
| Product Code | FBM |
| Date Received | 2003-11-17 |
| Returned To Mfg | 2003-10-22 |
| Model Number | NA |
| Catalog Number | CD775 |
| Lot Number | CC306604 |
| ID Number | NA |
| Device Expiration Date | 2008-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 485384 |
| Manufacturer | CORE DYNAMICS |
| Manufacturer Address | 11222 ST JOHN'S INDUS. PKWY N JACKSONVILLE FL 322466675 US |
| Baseline Brand Name | CORE ENTREE II VALVE/REDUCER |
| Baseline Generic Name | ENDO VALVE REDUCER |
| Baseline Model No | NA |
| Baseline Catalog No | CD775 |
| Baseline ID | NA |
| Baseline Device Family | ENDOSCOPIC TROCAR/CANNULA SYSTEMS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911813 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-17 |