MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-28 for DYNJ46424C manufactured by Medline Industries Inc..
[118723749]
It was reported that during an anterior cervical diskectomy and fusion at cervical 6-7 with c-arm, the cautery device caught fire. Reportedly, at the time of the fire, the cautery device had been put "back into the pouch until next use. " this incident occurred after the cautery device was initially used. According to the facility, the fire "went out after 2 seconds by itself. " it was not identified which part of the device caught on fire. A new cautery device and tip were obtained and the procedure was completed without further reported incident. The patient was under general anesthesia at the time of this incident. There was no reported increase in overall procedure time or need for additional anesthesia. The facility did not identify if the cautery device had been on cut or coag mode prior to the incident. The generator's make, model, settings, and mode were not identified by the facility. There was no reported impact to the patient, to a staff member, or to the procedure. The cautery device was returned to the manufacturer for evaluation. The cautery device functioned nominally in both cut and coag modes. The cautery device shut off immediately after the push button was released. There was no fire or delay in functionality noted during sample investigation. The reported product issue could not be confirmed. A root cause could not determined. 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
[118723850]
It was reported that during an anterior cervical diskectomy and fusion at cervical 6-7 with c-arm, the cautery device caught fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2018-00045 |
| MDR Report Key | 7823573 |
| Date Received | 2018-08-28 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-08-09 |
| Date Added to Maude | 2018-08-28 |
| 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 | CAUTERY DEVICE IN NEURO BASIC |
| Product Code | OJG |
| Date Received | 2018-08-28 |
| Returned To Mfg | 2018-08-27 |
| Catalog Number | DYNJ46424C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-28 |