MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-05-29 for ETHER320 manufactured by Sterilmed, Inc..
[15912382]
It was reported that during surgery it was initially noticed that the clips seemed to be scissoring, then it was noticed that they were not fully forming on the structures, finally it was noticed they were not loading correctly. It was felt that the structures were sufficiently occluded, and the patient was closed and sent to post-op. In post-op, the patient started showing signs of potential complication and was taken back into surgery. It was found that one or more of the vascular structures had not been sufficiently occluded and the structures were then further ligated. Patient was stabilized and was sent home without further incident. Additional information was requested but no further information was provided. A supplemental report will be filed if additional information is received.
Patient Sequence No: 1, Text Type: D, B5
[16140240]
The device was not returned to the manufacturer as of the date of this report. A supplemental report will be sent after the device evaluation if the device is received.
Patient Sequence No: 1, Text Type: N, H10
[24415627]
Additional information reported that the device discarded by the user facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00022 |
| MDR Report Key | 4806211 |
| Report Source | 05,07 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-04 |
| Date Mfgr Received | 2015-05-04 |
| Date Added to Maude | 2015-05-29 |
| 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 | PATRICIA KAUFMAN |
| Manufacturer Street | 5010 CHESHIRE PARKWAY SUITE 2 |
| Manufacturer City | PLYMOUTH MN 55369 |
| Manufacturer Country | US |
| Manufacturer Postal | 55369 |
| Manufacturer Phone | 7634888321 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLIP, IMPLANTABLE, REPROCESSED |
| Product Code | NMJ |
| Date Received | 2015-05-29 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2015-05-29 |