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 2016-01-25 for ETHER320 manufactured by Sterilmed, Inc..
[36765706]
The device has not been returned to the manufacturer at the time of this report. A supplemental form will be submitted upon evaluation once the device is returned. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[36765707]
It was reported the during a surgical procedure clips malformed into a scissor shape and the device would not release the clip properly, not releasing the clip. No patient injury or intervention was reported, as the doctor quit using the device once it was noticed that the clips were scissoring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2016-00007 |
| MDR Report Key | 5388717 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-01-25 |
| Date of Report | 2015-12-31 |
| Date of Event | 2015-12-30 |
| Date Mfgr Received | 2015-12-31 |
| Device Manufacturer Date | 2015-08-26 |
| Date Added to Maude | 2016-01-25 |
| 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 | 2016-01-25 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Lot Number | 1881179 |
| Device Expiration Date | 2016-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-01-25 |