MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-02-26 for ENTREE II 5-12MM VALVE/REDUCER CD775 manufactured by Conmed Corporation.
[1333800]
It was reported: "the doctor was performing a lap nissen fundoplication on jan 29th, and that the pt came back to the hosp the very next day on the 30th due to complications having nothing to do with the core trocar. During the pt's 2nd visit to the hosp, somehow it was discovered that a portion of the core dynamic seal was left inside the pt. It is not known exactly how it got there, nor it is known how it was not noticed at the time of the actual procedure. At the beginning of the case, as well as during the case the doctor struggled to insert instruments through the seal of the trocar the doctor was very rough with the insertion of instruments, and appeared to be catching on the seal on the way into the cannula. The doctor seemed to have to force the instrument through the seal".
Patient Sequence No: 1, Text Type: D, B5
[8440289]
Multiple attempts have been made to obtain add'l info from facility without cooperation. At this time, it is unk if the seal was retrieved from the pt. Conmed will continue to attempt to gather add'l info; however, user facility appears to be unwilling to answer questions. Once an investigation, and further attempts to gather add'l info have been completed, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2010-00020 |
| MDR Report Key | 1622490 |
| Report Source | 06,07 |
| Date Received | 2010-02-26 |
| Date of Report | 2010-02-25 |
| Date of Event | 2010-01-29 |
| Date Mfgr Received | 2010-02-01 |
| Date Added to Maude | 2010-03-09 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TYLER CORCORN |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243059 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH RD. |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTREE II 5-12MM VALVE/REDUCER |
| Generic Name | ENTREE II 5-12 MM VALVE/REDUCER |
| Product Code | FBM |
| Date Received | 2010-02-26 |
| Model Number | NA |
| Catalog Number | CD775 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-02-26 |