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 2016-11-18 for ETHER320 manufactured by Sterilmed, Inc..
[60433700]
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
[60433701]
It was reported by the customer that after a few fires of the clip applier device the clips started to twist/scissor. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[63301487]
The returned clip applier was fired until all remaining clips were spent. The device produced clips of proper pinch and alignment. No defect was detected during the function testing of the device. Based on this evidence the account's complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00084 |
| MDR Report Key | 6112695 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-18 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-10-25 |
| Date Mfgr Received | 2016-12-15 |
| Device Manufacturer Date | 2016-06-10 |
| Date Added to Maude | 2016-11-18 |
| 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 | 11400 73RD AVE N |
| Manufacturer City | MAPLE GROVE 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 | 2016-11-18 |
| Returned To Mfg | 2016-12-15 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Lot Number | 1951481 |
| Device Expiration Date | 2017-06-10 |
| 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 | 2016-11-18 |