MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-03 for ETHER320 manufactured by Sterilmed, Inc..
[59078801]
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 not able to be reviewed as no lot number was given.
Patient Sequence No: 1, Text Type: N, H10
[59078802]
It was reported that the device misfired by twisting staples and scissoring. No patient harm was reported. Additional information was requested, but additional information was not available.
Patient Sequence No: 1, Text Type: D, B5
[62585212]
The complaint device was function tested and fired until all remaining clips were spent. The device displayed no defect and every clip that was fired displayed the proper alignment and pinch. No defect was found with the performance 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 | 2134070-2016-00080 |
| MDR Report Key | 6076652 |
| Date Received | 2016-11-03 |
| Date of Report | 2016-12-08 |
| Date Mfgr Received | 2016-12-07 |
| 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 | 2016-12-07 |
| Model Number | ETHER320 |
| Catalog Number | ETHER320 |
| 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 |