MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-16 for CDS983939I manufactured by Medtronic.
[70328446]
It was reported approximately ten minutes into a vats procedure the coated tip of a cautery device was "shredding" during use and particles were deposited within the surgical site. The physician was able to successfully remove the particles using suction. The procedure was completed without further incident. The device was returned and the complaint confirmed.
Patient Sequence No: 1, Text Type: N, H10
[70328447]
It was reported coating from the tip of a covidien cautery fell into the surgical site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2017-00009 |
| MDR Report Key | 6411499 |
| Date Received | 2017-03-16 |
| Date of Report | 2017-03-16 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2016-11-01 |
| Date Added to Maude | 2017-03-16 |
| 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 | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8477703962 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | COVIDIEN CAUTERY DEVICE IN VATS/LAPAROSCOPY PACK |
| Product Code | FDE |
| Date Received | 2017-03-16 |
| Catalog Number | CDS983939I |
| Lot Number | 16KB3700 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 710 MEDTRONIC PARKWAY MINNEEAPOLIS MN 554325604 US 554325604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-16 |