MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-02 for CDS760047U manufactured by Medtronic (covidien).
[113185975]
It was reported that during an unidentified procedure, the "cautery tip ignited during use. " after multiple good-faith attempts, the customer was unable or unwilling to provide additional patient, product, or procedural information related to this incident. No serious injury, medical intervention, or follow-up care was originally reported. No impact to a patient, a patient's stability, a patient's plan of care, or to the unidentified procedure was originally reported. No sample was returned to the manufacturer for evaluation. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[113185976]
It was reported that during an unidentified procedure, the "cautery tip ignited during use. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00034 |
| MDR Report Key | 7654363 |
| Date Received | 2018-07-02 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-05-01 |
| Date Mfgr Received | 2018-05-16 |
| Date Added to Maude | 2018-07-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | COVIDIEN CAUTERY DEVICE IN DBD-ABD HYSTERECTOMY CDS |
| Product Code | OJF |
| Date Received | 2018-07-02 |
| Catalog Number | CDS760047U |
| Lot Number | 17VB3343 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC (COVIDIEN) |
| Manufacturer Address | 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 554325604 US 554325604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-02 |