MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-11-05 for ETHER320 ER320 manufactured by Sterilmed, Inc..
[5007346]
It was reported that during a laparoscopic cholecystectomy the clip failed to remain closed after. Firing. The clip would not close completely and was partially closed. Some clips were successfully fired prior to the event, but the number was unk. The device was not fired over other clips. The issue was noticed immediately, and the device was replaced. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[12567023]
The device was returned to the mfr and will undergo device eval. A supplemental report will be sent when the eval is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00187 |
| MDR Report Key | 4262124 |
| Report Source | 05,07 |
| Date Received | 2014-11-05 |
| Date of Report | 2014-10-09 |
| Date of Event | 2014-09-22 |
| Date Mfgr Received | 2014-10-09 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2014-11-20 |
| 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 | 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 | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2014-11-05 |
| Returned To Mfg | 2014-10-24 |
| Model Number | ETHER320 |
| Catalog Number | ER320 |
| Lot Number | 1786060 |
| Device Expiration Date | 2015-07-31 |
| 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 | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-05 |