MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-06-30 for VALLEYLAB E6008 manufactured by Covidien Mfg Dc Boulder.
[78895831]
The return of the unit has been requested. To date it has not been received for evaluation. Additional questions in regard to the incident have also been asked. If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[78895832]
The customer reported that a fire occurred during a procedure in which the device was in use. The fire was seen around the cable attached to the device but not on the pencil tip. The customer indicated that the monopolar / bipolar cable was connected to the generator and the fire occurred after monopolar 1 cable was changed in order to replace the pencil tip. The customer indicated that the activation was tested with the footswitch and they stated that the generator cable may have been grasped by the forceps, leading to damage of the device and possibly causing the fire. The flame was immediately extinguished with no patient harm. New devices were used to complete the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[92948490]
No eval explain code. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1717344-2017-05523 |
| MDR Report Key | 6682870 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-06-30 |
| Date of Report | 2017-06-14 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-06-14 |
| Date Added to Maude | 2017-06-30 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 2034925267 |
| Manufacturer G1 | COVIDIEN MFG DC BOULDER |
| Manufacturer Street | 5920 LONGBOW DR |
| Manufacturer City | BOULDER CO 803013299 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 803013299 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VALLEYLAB |
| Generic Name | UNIT, ELECTROSURGICAL ANDCOAGULATION, WITH ACCESSORIES |
| Product Code | BWA |
| Date Received | 2017-06-30 |
| Model Number | E6008 |
| Catalog Number | E6008 |
| Lot Number | 557494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG DC BOULDER |
| Manufacturer Address | 5920 LONGBOW DR BOULDER CO 803013299 US 803013299 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-30 |