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 2016-11-03 for ETHER320 manufactured by Sterilmed, Inc..
[59066726]
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
[59066727]
It was reported that the clips were not coming out or malformed, clips do not slide into position. Additional information was requested and received. It was further reported the clip was crossing over itself and or turning sideways in the jaw so it could not be used. It was also reported that about every third clip it would come out and fall away from the applier before it could be used. There was no harm to patient. Case completion was delayed while a new package was opened.
Patient Sequence No: 1, Text Type: D, B5
[61528829]
The device was returned to the manufacturer. The clip applier was fired until all remaining clips were spent. The device displayed no defect during its testing. All clips were fired with the proper pinch and alignment. Based on these observations the device's complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2134070-2016-00079 |
| MDR Report Key | 6075894 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-11-03 |
| Date of Report | 2016-10-10 |
| Date Mfgr Received | 2016-12-02 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2016-11-03 |
| 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 | 2016-11-03 |
| Returned To Mfg | 2016-12-02 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| Lot Number | 1938416 |
| Device Expiration Date | 2017-04-01 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-11-03 |