MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-12-18 for ETHMCL20 manufactured by Sterilmed, Inc..
[5179181]
It was reported that the device misfired and severed a small vessel. After the event, it was realized that there was no clip. There was nothing done to repair the vessel. Another device was used to complete the procedure. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[12672572]
The device was returned to the mfr and is awaiting investigation. A supplemental report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00202 |
| MDR Report Key | 4355710 |
| Report Source | 05,07 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-11-18 |
| Date Mfgr Received | 2014-11-18 |
| Device Manufacturer Date | 2013-02-07 |
| Date Added to Maude | 2015-01-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA KAUFMAN |
| Manufacturer Street | 11400 73RD AVE. NORTH |
| Manufacturer City | MAPLE GROVE MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Product Code | NMJ |
| Date Received | 2014-12-18 |
| Returned To Mfg | 2014-12-16 |
| Model Number | ETHMCL20 |
| Catalog Number | ETHMCL20 |
| Lot Number | 1625943 |
| Device Expiration Date | 2014-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE. NORTH MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-18 |