MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-11 for VALLEYLAB MONOPOLAR LAPAROSCOPIC CORD, REUSABLE E2999 manufactured by Covidien.
[113656930]
On (b)(6) 2018 during a robotic surgery, there was a small fire at the electrocautery cord and instrument interface. This was recognized immediately and put out. The pt and staff were not harmed by the fire and the instrument was no longer used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078316 |
| MDR Report Key | 7677554 |
| Date Received | 2018-07-11 |
| Date of Report | 2018-07-09 |
| Date of Event | 2018-06-14 |
| Date Added to Maude | 2018-07-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEYLAB MONOPOLAR LAPAROSCOPIC CORD, REUSABLE |
| Generic Name | REUSABLE MONOPOLAR CAUTERY CORD |
| Product Code | BWA |
| Date Received | 2018-07-11 |
| Returned To Mfg | 2018-07-09 |
| Catalog Number | E2999 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | FONTANA CA 92335 US 92335 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-11 |