MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-07-08 for MONOPOLAR CABLE 10 FEET 600290 manufactured by J. Jamner Surgical Instruments.
[15499192]
The customer reported that a bovie machine: valley lab fx, (b) (4) was used with a jarit hook electrode (b) (4). Setting: 25 coag fulgarate, 1 cut, o blend. The physician attempted to use the hook electrode with a monopolar cord. The monopolar cord made a "sizzle" noise, then a "pop". The cord sparked and glowed orange with a tiny flame. The area of the cord melted (or burned) completely in two, approximately 1/8" from the part of the cord that plugs into the hook electrode. No burns were noted to the drapes. No injury to the patient or staff. The return electrode was on the patient correctly, plugged into the generator with the green indicator (circuit complete) on.
Patient Sequence No: 1, Text Type: D, B5
[15727383]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2009-00012 |
| MDR Report Key | 1472717 |
| Report Source | 05 |
| Date Received | 2009-07-08 |
| Date of Report | 2009-07-08 |
| Date of Event | 2009-06-04 |
| Date Facility Aware | 2009-06-23 |
| Date Mfgr Received | 2009-06-23 |
| Date Added to Maude | 2009-10-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONOPOLAR CABLE 10 FEET |
| Generic Name | NA |
| Product Code | HFG |
| Date Received | 2009-07-08 |
| Catalog Number | 600290 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. JAMNER SURGICAL INSTRUMENTS |
| Manufacturer Address | HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-08 |