MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-05-24 for STO27040G manufactured by Sterilmed, Inc..
[2661192]
It was reported that an electrode broke during a procedure.
Patient Sequence No: 1, Text Type: D, B5
[9977661]
Final investigation showed that the cutting loop of the device was broken. The piece that broke off was returned with the device. It was not possible to determine what caused the cutting loop to break during use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2012-00095 |
| MDR Report Key | 2591228 |
| Report Source | 01,08 |
| Date Received | 2012-05-24 |
| Date of Report | 2011-10-14 |
| Date Mfgr Received | 2011-10-14 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2012-06-05 |
| 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 | 2011-10-19 |
| Model Number | STO27040G |
| 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 |