MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2012-05-24 for 27040G manufactured by Sterilmed, Inc..
[2661667]
It was reported that an endoscopic electrode had an improper angle to it.
Patient Sequence No: 1, Text Type: D, B5
[9867967]
Final investigation showed that the loop of the device was broken, and there were burned areas on the loop and sheathing. It appeared that a piece of the electrode loop was missing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2012-00074 |
| MDR Report Key | 2591238 |
| Report Source | 01,05,08 |
| Date Received | 2012-05-24 |
| Date of Report | 2011-08-12 |
| Date Mfgr Received | 2011-08-12 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-09-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TRICIA SCHRATER |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634883211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | ENDOSCOPIC ELECTRODE (NLW) |
| Product Code | NLW |
| Date Received | 2012-05-24 |
| Returned To Mfg | 2011-08-24 |
| Model Number | 27040G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-24 |