MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-06-17 for CORE 5-12MM REDUCER CD720 manufactured by Conmed Corp..
[20162068]
It was reported that during a lap appendectomy, they had a difficult time passing the stapler through the reducer. Pressure was exerted and the internal valve dislplaced and fell into the surgical site. It was retrieved. There was no injury to the pt.
Patient Sequence No: 1, Text Type: D, B5
[20604053]
I am attempting to obtain the device for eval. If the device is obtained, i will file a suplemental report at that time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317214-2005-00075 |
| MDR Report Key | 743839 |
| Report Source | 05,06 |
| Date Received | 2005-06-17 |
| Date of Report | 2005-05-19 |
| Date Mfgr Received | 2005-03-19 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2006-08-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CRISINO SUPERVISOR |
| Manufacturer Street | 525 FRENCH RD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243070 |
| 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 5-12MM REDUCER |
| Generic Name | TROCAR SYSTEM REDUCER |
| Product Code | FBM |
| Date Received | 2005-06-17 |
| Model Number | NA |
| Catalog Number | CD720 |
| Lot Number | 0412231 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 630807 |
| Manufacturer | CONMED CORP. |
| Manufacturer Address | * UTICA NY 13501 US |
| Baseline Brand Name | CORE 5/12MM REDUCER/SEAL |
| Baseline Generic Name | REDUCER/SEAL FOR TROCAR SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | CD720 |
| Baseline ID | NA |
| Baseline Device Family | ENTREE II TROCAR SYSTEM |
| 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 | 2005-06-17 |