MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-11-10 for ETHER420 ER420 manufactured by Sterilmed, Inc..
[5298049]
It was reported that during a laparoscopic hepatectomy when trying to load the device, clips failed to load at all, loaded only "halfway" or fired two at a time on top of each other. It was also reported that clips came out crossed. It was uncertain whether any clips were applied correctly prior to the issues. Some clips were fired outside the body, and those clips also had one or more of the problems. There was no torquing of the device. Another device was used to complete the procedure. There was a delay caused. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[12587823]
The device was returned to the manufacturer for device evaluation. A supplemental report will be sent when device evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2014-00188 |
| MDR Report Key | 4280414 |
| Report Source | 05,07 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-10-03 |
| Date Mfgr Received | 2014-10-14 |
| Device Manufacturer Date | 2014-02-01 |
| Date Added to Maude | 2014-12-01 |
| 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 | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2014-11-10 |
| Returned To Mfg | 2014-10-24 |
| Model Number | ETHER420 |
| Catalog Number | ER420 |
| Lot Number | 1747087 |
| Device Expiration Date | 2015-02-28 |
| 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 | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-10 |