MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-22 for VALLEYLAB E0510 manufactured by Medtronic/covidien/valleylab.
[87038606]
On (b)(6) 2017 during an uneventful laparoscopic cholecystectomy in the main operating room, a flame was noted while using a covidien valleylab laparoscopic single-use/disposable monopolar cautery cord ((b)(4)). The flame occurred near the junction where the cord connects to the cautery instrument. The resident surgeon's glove was burned and he sustained a first degree burn to the hand. The pt was not harmed. The equipment was immediately sequestered and surgery was completed without further incident. We are aware of at least one other medical center that has had overheating issues with this cautery cord. We have now discontinued the use of this cord and have switched to a different cord from a different mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072309 |
| MDR Report Key | 6886534 |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-29 |
| Date Added to Maude | 2017-09-22 |
| 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 |
| Generic Name | UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES |
| Product Code | BWA |
| Date Received | 2017-09-22 |
| Model Number | E0510 |
| Catalog Number | E0510 |
| Lot Number | 1610005X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC/COVIDIEN/VALLEYLAB |
| Manufacturer Address | MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-22 |