MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-08-04 for CORE ENTRE II VALVE/REDUCER CD775 manufactured by Conmed Corp..
[385673]
It was reported that "during a lap procedure an auto-suture device was inserted through the reducer and an inner seal tore out. It fell into the pt. It was retrieved. There was no pt injury and the procedure was not altered. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-2005-00092 |
| MDR Report Key | 627340 |
| Report Source | 05 |
| Date Received | 2005-08-04 |
| Date of Report | 2005-07-07 |
| Date of Event | 2005-06-01 |
| Date Mfgr Received | 2005-07-07 |
| Date Added to Maude | 2005-08-17 |
| 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, SUPERVISOR |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243078 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORE ENTRE II VALVE/REDUCER |
| Generic Name | TROCAR SYSTEM REDUCER |
| Product Code | FBM |
| Date Received | 2005-08-04 |
| Returned To Mfg | 2005-07-15 |
| Model Number | NA |
| Catalog Number | CD775 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 616968 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | * UTICA NY 13502 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 | 2005-08-04 |