MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-03 for CORE ADAPTOR CD720 * manufactured by Conmed Corporation.
[432776]
During a laparoscopic appendectomy, the diaphragm of the core trocar would not allow the stapler to pass through the opening (it would pass only with lots of pressure). One filter passed through the adaptor and into the abdominal cavity. The filter was then retrieved laparoscopically with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 641300 |
| MDR Report Key | 641300 |
| Date Received | 2005-05-03 |
| Date of Report | 2005-05-03 |
| Date of Event | 2005-04-25 |
| Report Date | 2005-05-03 |
| Date Reported to FDA | 2005-05-03 |
| Date Added to Maude | 2005-10-18 |
| 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 | 0 |
| 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 | CORE ADAPTOR |
| Generic Name | CORE ADAPTOR |
| Product Code | FBM |
| Date Received | 2005-05-03 |
| Model Number | CD720 |
| Catalog Number | * |
| Lot Number | 0412231 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 630807 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 310 BROAD STREET 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 | 2005-05-03 |