MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-11-14 for ETHER320 manufactured by Sterilmed, Inc..
[59753171]
The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[59753172]
It was reported that the clip appliers misfired, resulting in a twisted/scissoring of the clip. It was reported that there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
[62584835]
The complaint device was returned empty and as such could not be function tested. No visual defects were noted in the alignment of the jaws. Without being able to fire a clip from the complaint device the account's complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00082 |
| MDR Report Key | 6099052 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-14 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-10-11 |
| Date Mfgr Received | 2016-12-07 |
| Device Manufacturer Date | 2016-01-14 |
| Date Added to Maude | 2016-11-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JASON ANDERSON |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2016-11-14 |
| Returned To Mfg | 2016-12-07 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Lot Number | 1921261 |
| Device Expiration Date | 2017-01-14 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |