MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-01-15 for CONMED CD730BG manufactured by Conmed Corporation.
[22264996]
5-12mm entree ii valve/reducer inserted into abdomen. When laparoscopic camera introduced, a piece of plastic reducer broke off from reducer and entered peritoneum. Doctor able to retrieve plastic piece from peritoneum without incident. Charge nurse notified and viewed broken pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4420833 |
| MDR Report Key | 4420833 |
| Report Source | * |
| Date Received | 2015-01-15 |
| Date of Report | 2015-01-15 |
| Date of Event | 2014-12-03 |
| Report Date | 2015-01-15 |
| Date Reported to FDA | 2015-01-15 |
| Date Added to Maude | 2015-01-15 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONMED |
| Generic Name | VALVE/REDUCER |
| Product Code | FBM |
| Date Received | 2015-01-15 |
| Model Number | CD730BG |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH RD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-01-15 |