MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2010-04-07 for IRE SINGLE ELECTRODE PROBE 20400102 manufactured by Angiodynamics.
[20309590]
During ire delivery for the initial and first pull back, popping noises were audible. When dr. (b)(6) pulled back again, the popping noises sounded more like muffled arcing, however, there was no high current conditions. During the 5th pull back, dr. (b)(6) noticed small sparks coming from one of the needles at the surface of the skin. Close inspection of the device revealed what looks to be a slice into the insulation half way up the insulation.
Patient Sequence No: 1, Text Type: D, B5
[20376886]
Lot history record review: the lot number was not provided. A ship history showed that the following lot had been shipped in the last 6 months: (b)(4). The complaint info was forwarded to pronet. Pronet reviewed the possible lot history records and found no variances related to this event were observed. Review of returned sample: confirmed the reported complaint. Conclusion: the complaint sample has been sent to the vendor for further eval. Frequency has increased but the severity of this event is not greater than usual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2010-00013 |
| MDR Report Key | 1657895 |
| Report Source | 05,06,07 |
| Date Received | 2010-04-07 |
| Date of Report | 2010-03-31 |
| Date of Event | 2010-03-10 |
| Date Mfgr Received | 2010-03-15 |
| Date Added to Maude | 2011-02-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGARET MCGUIRE |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IRE SINGLE ELECTRODE PROBE |
| Generic Name | IRE SINGLE ELECTRODE PROBE |
| Product Code | OHJ |
| Date Received | 2010-04-07 |
| Returned To Mfg | 2010-03-19 |
| Catalog Number | 20400102 |
| Lot Number | NOT REPORTED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-07 |