MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-19 for DYNJ902703D manufactured by Medtronic (covidien).
[127943687]
It was reported that during a bilateral mastectomy the tip of the covidien cautery device produced a flame. The facility contact stated that when the flame was identified, the tip of the covidien cautery device was changed and no further incident was reported. The facility contact stated that there was no impact or adverse effect to the patient. No further patient, product, or procedural information related to the incident was reported to the procedure pack manufacturer. It is unknown at what point in the procedure the reported incident occurred. It is unknown if the reported incident occurred during first or subsequent use of the covidien cautery device. No sample of the covidien cautery device was returned to the procedure pack manufacturer. Due to the reported flame, 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
[127943688]
It was reported that during a bilateral mastectomy the tip of the covidien cautery device produced a flame.
Patient Sequence No: 1, Text Type: D, B5
[129379502]
Additional information was received by the procedure pack manufacturer related to the reported incident of a covidien cautery device tip that produced a flame during a bilateral mastectomy. It was reported that this occurred after first use of the covidien cautery device. When the flame was identified, the cautery tip was replaced with a new one. The procedure was completed without further reported incident. The patient did not require additional anesthesia to complete the procedure. There was no impact or adverse effect to the patient, the procedure, or to a staff member. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423395-2018-00058 |
| MDR Report Key | 8084118 |
| Date Received | 2018-11-19 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2018-10-26 |
| Date Added to Maude | 2018-11-19 |
| 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 | 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 BREAST PACK |
| Product Code | FTN |
| Date Received | 2018-11-19 |
| Catalog Number | DYNJ902703D |
| Lot Number | 18FBM721 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-19 |