MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-09 for CORE 5-12MM REDUCER VALVE C0720 manufactured by Conmed Corp..
[36739280]
As soon as the engineer evaluation is completed, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[36739281]
It was reported that, "during a surgical procedure, the inner seal tore out of the valve when a 10mm weck reusable clip applier was passed through it. The seal fell into the surgical site and was retrieved. There was no patient injury and the procedure was not altered. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317214-2004-00101 |
| MDR Report Key | 5369598 |
| Date Received | 2005-09-09 |
| Date of Report | 2005-08-09 |
| Date of Event | 2005-08-09 |
| Date Mfgr Received | 2005-08-09 |
| Date Added to Maude | 2016-01-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NANCY CRISINO, RA/QA SUPERVISOR |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243078 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CORE 5-12MM REDUCER VALVE |
| Generic Name | TROCAR SYSTEM REDUCER |
| Product Code | FBM |
| Date Received | 2005-09-09 |
| Returned To Mfg | 2005-08-15 |
| Model Number | NA |
| Catalog Number | C0720 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | UTICA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-09 |